## Protocol Section
### Identification Module
**NCT ID:** NCT01076179

**Acronym:** PROTEKT

**Brief Title:** Kaletra in Combination With Antiretroviral Agents

**Official Title:** KALETRA in Combination With New Substances (PROTEKT)

#### Organization Study ID Info
**ID:** P11-021
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
### Status Module
#### Completion Date
**Date:** 2016-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-05-19

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-05-19

**Type:** ACTUAL

**Results First Submit Date:** 2017-01-18

**Results First Submit QC Date:** 2017-05-18

#### Start Date
**Date:** 2008-09

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2010-02-26
**Type:** ESTIMATED
**Study First Submit Date:** 2010-02-24
**Study First Submit QC Date:** 2010-02-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AbbVie (prior sponsor, Abbott)

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra.

**Detailed Description:** This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

### Conditions Module

**Conditions:**

- Human Immunodeficiency Virus

**Keywords:**

- Infection

- Rilpivirine

- CCR5 antagonists

- Etravirine

- Human Immunodeficiency Virus

- Maraviroc

- Safety and efficacy

- Non nucleoside reverse transcriptase inhibitors (NNRTIs)

- Integrase inhibitors

- Raltegravir

- Kaletra

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 502

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists

**Label:** Human Immunodeficiency Virus (HIV)-Infected Participants

### Outcomes Module

#### Other Outcomes

**Description:** Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.

**Measure:** Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load

**Time Frame:** Baseline (Week 0) to Week 144

**Description:** Time to virologic failure was defined by the earliest occurrence of:

1. HIV-1 RNA \> 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA \< 50 copies/mL,
2. HIV-1 RNA \> 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA \< 50 copies/mL but subsequently did not have HIV-1 RNA \> 400 copies/mL on 2 consecutive occasions, or
3. Day 1 if the participant never achieved HIV-1 RNA \< 50 copies/mL during study participation.

A participant who prematurely discontinued study drug with HIV-1 RNA \< 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c).

**Measure:** Time to Virologic Failure

**Time Frame:** Baseline (Week 0) to Week 144

#### Primary Outcomes

**Description:** Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').

**Measure:** Prevalence of Adverse Events (Weeks 0-144), Per Event

**Time Frame:** Weeks 0 to 144

**Description:** Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').

**Measure:** Prevalence of Adverse Events (Weeks 0-144), Per Participant

**Time Frame:** Weeks 0 to 144

#### Secondary Outcomes

**Description:** Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.

**Measure:** Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count

**Time Frame:** Baseline (Week 0) to Week 144

**Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.

**Measure:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis

**Time Frame:** Baseline (Week 0) to Week 144

**Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.

**Measure:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis

**Time Frame:** Baseline (Week 0) to Week 144

**Measure:** Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL

**Time Frame:** From Week 0 to Week 144

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.

Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With Lopinavir (LPV) Resistance at Baseline

**Time Frame:** Baseline (Week 0)

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With LPV Resistance During Follow-Up

**Time Frame:** up to Week 144

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.

Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With Protease Inhibitor (PI) Resistance at Baseline

**Time Frame:** Baseline (Week 0)

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With PI Resistance During Follow-Up

**Time Frame:** Up to Week 144

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With INI Resistance at Baseline

**Time Frame:** Baseline (Week 0)

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With INI Resistance During Follow-Up

**Time Frame:** up to Week 144

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With NNRTI Resistance at Baseline

**Time Frame:** Baseline (Week 0)

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With NNRTI Resistance During Follow-Up

**Time Frame:** up to Week 144

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline

**Time Frame:** Baseline (Week 0)

**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.

**Measure:** Number of Participants With NRTI Resistance During Follow-Up

**Time Frame:** up to Week 144

**Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.

**Measure:** Number of Participants With HIV-1 Coreceptor Tropism at Baseline

**Time Frame:** Baseline (Week 0)

**Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.

**Measure:** Number of Participants With HIV-1 Coreceptor Tropism During Follow-up

**Time Frame:** up to Week 144

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients ≥ 18years of age
* Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study)
* HIV-1 infection
* Patients treated with KALETRA®, independent from their participation in this study
* Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study

Exclusion Criteria:

* Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists
* Severe liver insufficiency
* No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or St. John's wort

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Community sample: HIV-positive patients

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** AbbVie Deutschland GmbH & Co. KG, Medical Department

**Name:** Bianca Wittig, MD

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://rxabbvie.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007154

- Term: Immune System Diseases

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012897

- Term: Slow Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: HIGH

- As Found: Human Immunodeficiency Virus

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: Human Immunodeficiency Virus

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: HIGH

- As Found: Immunodeficiency

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15700

- Name: Slow Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000163

- Term: Acquired Immunodeficiency Syndrome

- ID: D000015658

- Term: HIV Infections

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M295

- Name: Rilpivirine

- Relevance: LOW

- As Found: Unknown

- ID: M20935

- Name: Reverse Transcriptase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M1852

- Name: Maraviroc

- Relevance: LOW

- As Found: Unknown

- ID: M333

- Name: Raltegravir Potassium

- Relevance: LOW

- As Found: Unknown

- ID: M21386

- Name: Integrase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M339955

- Name: Etravirine

- Relevance: LOW

- As Found: Unknown

- ID: M21385

- Name: HIV Integrase Inhibitors

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

#### Removed Countries

- Country: Germany

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Serious adverse events only were collected and coded by MedDRA. Per protocol, the number of participants with events were collected for each event, but from the source documentation to tell how many of the participants are counted in more than one adverse event (i.e., it is not possible to compute the Total Number of Participants Affected). Please see Outcome Measures 1 and 2 for these data.

#### Event Groups

**Group ID:** EG000

**Title:** HIV-infected Participants

**Description:** HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists

**ID:** EG000

**Serious Number Affected:** 30

**Serious Number At Risk:** 501

**Title:** HIV-infected Participants

**Frequency Threshold:** 0

#### Serious Events

**Term:** LYMPHADENOPATHY

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 501

**Term:** NEUTROPENIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CARDIAC FAILURE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ABDOMINAL PAIN

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DIARRHOEA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 501

**Term:** NAUSEA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** STOMATITIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** VOMITING

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ASTHENIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** FATIGUE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** MULTI-ORGAN FAILURE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 501

**Term:** OEDEMA PERIPHERAL

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** PYREXIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** HYPERBILIRUBINAEMIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** AIDS DEMENTIA COMPLEX

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ACUTE HEPATITIS C

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ANAL ABSCESS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CHLAMYDIAL INFECTION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CYTOMEGALOVIRUS INFECTION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** INFECTION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** INJECTION SITE ABSCESS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** LYMPHOGRANULOMA VENEREUM

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** PNEUMOCOCCAL SEPSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** PNEUMONIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** PNEUMONIA FUNGAL

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** SEPSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** SEPTIC SHOCK

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** SUBCUTANEOUS ABSCESS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** TUBERCULOSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** YERSINIA INFECTION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** FALL

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** RADIUS FRACTURE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ACTINOMYCES TEST POSITIVE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ALANINE AMINOTRANSFERASE INCREASED

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ASPARTATE AMINOTRANSFERASE INCREASED

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** GAMMA-GLUTAMYLTRANSFERASE INCREASED

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 501

**Term:** INFLAMMATORY MARKER INCREASED

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** STREPTOCOCCUS TEST POSITIVE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** TROPONIN INCREASED

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DEHYDRATION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DIABETES MELLITUS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** HYPERGLYCAEMIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** HYPONATRAEMIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 501

**Term:** METABOLIC DISORDER

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** FASCIITIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** FISTULA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** INTERVERTEBRAL DISC PROTRUSION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** BASAL CELL CARCINOMA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** BUSCHKE-LOWENSTEIN'S TUMOUR

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** KAPOSI'S SARCOMA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** NEUROENDOCRINE CARCINOMA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** PANCREATIC NEOPLASM

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ALTERED STATE OF CONSCIOUSNESS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CAROTID ARTERY ANEURYSM

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CAROTID ARTERY STENOSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CAROTID ARTERY THROMBOSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CEREBROVASCULAR ACCIDENT

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DEMENTIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** NERVOUS SYSTEM DISORDER

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** SEIZURE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** SYNCOPE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** TRANSIENT ISCHAEMIC ATTACK

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** VERTEBRAL ARTERY STENOSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** WHITE MATTER LESION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ACUTE PSYCHOSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DELUSION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DEPRESSION

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CHRONIC OBSTRUCTIVE PULMONARY DISEASE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** COUGH

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 501

**Term:** DYSPNOEA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DYSPNOEA EXERTIONAL

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** INTERSTITIAL LUNG DISEASE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** PULMONARY OEDEMA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** SPUTUM DISCOLOURED

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DECUBITUS ULCER

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** LIPODYSTROPHY ACQUIRED

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ARTERIAL STENOSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** ARTERIOSCLEROSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** CIRCULATORY COLLAPSE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** DEEP VEIN THROMBOSIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Term:** HYPERTENSIVE CRISIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 18.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 501

**Time Frame:** Up to Week 144

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 501

**Units:** Participants

### Group

**ID:** BG000

**Title:** HIV-infected Participants

**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.1

**Value:** 45.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 70

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 431

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** AbbVie (prior sponsor Abbott)
**Phone:** 800-633-9110
**Title:** Global Medical Services
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.1
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28.5
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 161.7
- **Upper Limit:** 
- **Value:** 54.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 369
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 148.5
- **Upper Limit:** 
- **Value:** 64.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 400
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 195.3
- **Upper Limit:** 
- **Value:** 78.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 414
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 214.4
- **Upper Limit:** 
- **Value:** 95.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 363
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 213.2
- **Upper Limit:** 
- **Value:** 107.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 344
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 247.7
- **Upper Limit:** 
- **Value:** 131.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 315
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 216.1
- **Upper Limit:** 
- **Value:** 125.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 300
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 223.9
- **Upper Limit:** 
- **Value:** 142.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 266
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 207.0
- **Upper Limit:** 
- **Value:** 143.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 265
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 219.8
- **Upper Limit:** 
- **Value:** 155.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 233
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 233.0
- **Upper Limit:** 
- **Value:** 170.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 219
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 243.3
- **Upper Limit:** 
- **Value:** 180.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 212
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 252.9
- **Upper Limit:** 
- **Value:** 190.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 212
**Units:** Participants
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 65.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 72.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73.7
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 369
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 400
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 414
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 363
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 344
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 315
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 300
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 266
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 55.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 265
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 60.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 233
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 219
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 212
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 212
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.8
- **Upper Limit:** 
- **Value:** 56.1
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 155
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 142
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 74
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
#### Outcome Measure 18
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.40
- **Upper Limit:** 
- **Value:** -1.37
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 389
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.63
- **Upper Limit:** 
- **Value:** -1.53
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 408
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.70
- **Upper Limit:** 
- **Value:** -1.45
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 413
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.69
- **Upper Limit:** 
- **Value:** -1.49
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 367
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.68
- **Upper Limit:** 
- **Value:** -1.46
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 347
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.62
- **Upper Limit:** 
- **Value:** -1.27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 320
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.65
- **Upper Limit:** 
- **Value:** -1.32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 304
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.64
- **Upper Limit:** 
- **Value:** -1.34
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 269
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.59
- **Upper Limit:** 
- **Value:** -1.36
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 265
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.67
- **Upper Limit:** 
- **Value:** -1.32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 233
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.73
- **Upper Limit:** 
- **Value:** -1.29
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 225
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.65
- **Upper Limit:** 
- **Value:** -1.33
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 213
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.68
- **Upper Limit:** 
- **Value:** -1.38
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 216
**Units:** Participants
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.2
- **Upper Limit:** 
- **Value:** 194.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Weeks 0 to 144
**Title:** Prevalence of Adverse Events (Weeks 0-144), Per Event
**Type:** PRIMARY
**Type Units Analyzed:** Adverse Events
**Unit of Measure:** percentage of adverse events
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 2
**Description:** Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, headache, fatigue, fever, other (listed as 'not specified').
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Weeks 0 to 144
**Title:** Prevalence of Adverse Events (Weeks 0-144), Per Participant
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 3
**Description:** Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0) to Week 144
**Title:** Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
**Type:** SECONDARY
**Unit of Measure:** cells/μL
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 4
**Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
**Parameter Type:** NUMBER
**Population Description:** Modified 'intent-to-treat' analysis: missing values were replaced by the last observed value of that variable (last observation carried forward method).
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0) to Week 144
**Title:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 5
**Description:** Changes in participants' CD4 cell counts were assessed by measuring the number of CD4 cells at scheduled visits planned as part of routine care.
**Parameter Type:** NUMBER
**Population Description:** 'As treated' analyses: participants with an assessment, missing data excluded. Number analyzed=participants with an assessment at given time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0) to Week 144
**Title:** Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 6
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Participants with an assessment
**Reporting Status:** POSTED
**Time Frame:** From Week 0 to Week 144
**Title:** Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL
**Type:** SECONDARY
**Unit of Measure:** weeks
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 7
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.

Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at Baseline
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0)
**Title:** Number of Participants With Lopinavir (LPV) Resistance at Baseline
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 8
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
**Reporting Status:** POSTED
**Time Frame:** up to Week 144
**Title:** Number of Participants With LPV Resistance During Follow-Up
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 9
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-Genotypic Resistance-Algorithm Deutschland (GRADE; available at www.hiv-grade.de.

Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at Baseline
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0)
**Title:** Number of Participants With Protease Inhibitor (PI) Resistance at Baseline
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 10
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment during follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 144
**Title:** Number of Participants With PI Resistance During Follow-Up
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 11
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at Baseline
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0)
**Title:** Number of Participants With INI Resistance at Baseline
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 12
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at follow-up (neither had available Baseline testing); since this was an observational study, resistance testing was performed at the discretion of the treating physician.
**Reporting Status:** POSTED
**Time Frame:** up to Week 144
**Title:** Number of Participants With INI Resistance During Follow-Up
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 13
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at Baseline
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0)
**Title:** Number of Participants With NNRTI Resistance at Baseline
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 14
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
**Reporting Status:** POSTED
**Time Frame:** up to Week 144
**Title:** Number of Participants With NNRTI Resistance During Follow-Up
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 15
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at Baseline
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0)
**Title:** Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 16
**Description:** Characterization of baseline resistance and development of resistance using the interpretation system HIV-GRADE (available at www.hiv-grade.de. Genotypic interpretation was performed using the HIV-GRADE algorithm updated in December 2015). "Susceptible" indicates full susceptibility of a virus to a certain drug without any limitations in terms of resistance. "Partial" resistance is indicated if severe limitations in susceptibility have to be expected and the drug can not count for a fully active drug any more. However, these drugs can still be very useful in situations with generally limited options (salvage). "Resistant" indicates that high level drug resistance has to be expected.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at follow-up; since this was an observational study, resistance testing was performed at the discretion of the treating physician.
**Reporting Status:** POSTED
**Time Frame:** up to Week 144
**Title:** Number of Participants With NRTI Resistance During Follow-Up
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 17
**Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Baseline.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Participants with an assessment at Baseline
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0)
**Title:** Number of Participants With HIV-1 Coreceptor Tropism at Baseline
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 18
**Description:** Participants with CCR5 tropic virus, CXC motif chemokine receptor 4 (CRCX4) tropic virus, or dual/mixed tropic virus at Follow-up.
**Population Description:** Since this was an observational study, resistance testing was performed at the discretion of the treating physician. No follow-up data on tropism was collected.
**Reporting Status:** POSTED
**Time Frame:** up to Week 144
**Title:** Number of Participants With HIV-1 Coreceptor Tropism During Follow-up
**Type:** SECONDARY
##### Group
**Description:** HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 19
**Description:** Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0) to Week 144
**Title:** Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** log copies/mL
##### Group
**Description:** HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
#### Outcome Measure 20
**Description:** Time to virologic failure was defined by the earliest occurrence of:

1. HIV-1 RNA \> 400 copies/mL confirmed on 2 consecutive occasions after achieving at least 1 HIV-1 RNA \< 50 copies/mL,
2. HIV-1 RNA \> 400 copies/mL at the final on-study visit if the participant had previously experienced at least 1 HIV-1 RNA \< 50 copies/mL but subsequently did not have HIV-1 RNA \> 400 copies/mL on 2 consecutive occasions, or
3. Day 1 if the participant never achieved HIV-1 RNA \< 50 copies/mL during study participation.

A participant who prematurely discontinued study drug with HIV-1 RNA \< 50 copies/mL was censored from analysis at the time of discontinuation provided that he/she did not previously experience either (a), (b) or (c).
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Participants with an assessment
**Reporting Status:** POSTED
**Time Frame:** Baseline (Week 0) to Week 144
**Title:** Time to Virologic Failure
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** weeks
##### Group
**Description:** HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
**ID:** OG000
**Title:** HIV-infected Participants
### Participant Flow Module
#### Group
**Description:** Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists
**ID:** FG000
**Title:** HIV-infected Participants
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 502
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 501
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Has Results:** True