## Protocol Section
### Identification Module
**NCT ID:** NCT02212379

**Brief Title:** Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL

**Official Title:** Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study

#### Organization Study ID Info
**ID:** 2014-000828-24
#### Organization
**Class:** OTHER_GOV
**Full Name:** ANRS, Emerging Infectious Diseases
#### Secondary ID Infos
**Domain:** ANRS
**ID:** ANRS 163 ETRAL
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2018-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-04-27

**Type:** ACTUAL

**Last Update Submit Date:** 2021-03-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-02-05

**Type:** ACTUAL

**Results First Submit Date:** 2020-04-20

**Results First Submit QC Date:** 2021-01-11

#### Start Date
**Date:** 2015-01

**Status Verified Date:** 2021-03

#### Study First Post Date
**Date:** 2014-08-08
**Type:** ESTIMATED
**Study First Submit Date:** 2014-07-30
**Study First Submit QC Date:** 2014-08-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Merck Sharp & Dohme LLC

**Class:** INDUSTRY

**Name:** Janssen-Cilag Ltd.

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** ANRS, Emerging Infectious Diseases

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The primary endpoint was the proportion of participants with virological success at 48 weeks. Virological success is defined as the absence of 2 consecutive plasma viral load \>50 copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy \>90%, assuming a success rate \>95%, with a power of 80% and a 5%type-1 error. A total of 160 individuals was required to achieve the objective. The principal secondary endpoint is the proportion of patients in therapeutic success up to week 48 and 96.

### Conditions Module

**Conditions:**

- HIV-1 Infection

**Keywords:**

- Raltegravir

- Etravirine

- aged, 45 and over

- Viral load

- Efficacy

- Safety

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 170

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: raltegravir and etravirine

**Label:** raltegravir and etravirine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- raltegravir and etravirine

**Description:** Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.

**Name:** raltegravir and etravirine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.

The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96

**Measure:** Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96

**Time Frame:** at week48 and at week 96

#### Secondary Outcomes

**Description:** Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure

**Measure:** Percentage of Patients With Therapeutic Success at Week 48 and Week 96

**Time Frame:** weeks 48 and 96

**Measure:** Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96

**Time Frame:** weeks 48 and 96

**Measure:** Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)

**Time Frame:** weeks 48 and 96

**Description:** Time between the date of the study treatment initiation and the date of virological failure

**Measure:** Median Time of Virological Failure

**Time Frame:** week 96

**Measure:** Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL

**Time Frame:** weeks 48 and 96

**Measure:** Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure

**Time Frame:** week 96

**Measure:** Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL

**Time Frame:** week 96

**Measure:** Evolution of Total Cell-associated HIV-DNA

**Time Frame:** from day 0 to week 48 and week 96

**Measure:** Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio

**Time Frame:** from day 0 to week 48 and week 96

**Description:** Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.

**Measure:** Number of Participants Experiencing Adverse Events and Effects

**Time Frame:** From day 0 to week 48 and week 96

**Measure:** Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)

**Time Frame:** from day 0 to week 96

**Description:** The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.

Median percent change expressed as median (interquartile range (IQR))

**Measure:** Evolution of the Calibrated 5-year Framingham Risk Score

**Time Frame:** from day 0 to week 48 and at week 96

**Description:** Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula

**Measure:** Percent Change of Renal Function

**Time Frame:** from day 0 to week 96

**Description:** Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96

**Measure:** Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)

**Time Frame:** from day 0 to week 96

**Description:** • Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)

* Lumbar spine BMD, mg/cm2
* Total hip BMD, mg/cm2

**Measure:** Sub-study: Bone Mineral Density

**Time Frame:** from day 0, to week 48 and week 96

**Description:** • Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48

**Measure:** Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48

**Time Frame:** week 48

**Description:** • Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots

**Measure:** Inflammatory Parameters

**Time Frame:** from day 0 to week 96

**Measure:** Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96

**Time Frame:** day 0 and weeks 48 and 96

**Description:** The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).

**Measure:** Percentage of Participants Compliant With Treatment Program.

**Time Frame:** at week 0, week 48, and week 96

**Description:** We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)

**Measure:** Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots

**Time Frame:** from day 0, to week 48

**Measure:** Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples

**Time Frame:** from day 0, to week 48

**Description:** Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.

Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.

Ovarian reserve measure is AMH

**Measure:** Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96

**Time Frame:** from day 0, to week 96

**Description:** BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean

**Measure:** Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status

**Time Frame:** from day 0, to week 96

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Documented HIV-1 infection
* Age ≥ 45 years
* Naïve to integrase inhibitor and etravirine
* At least 6 months of stable antiretroviral therapy (ART) including a boosted protease inhibitor, whatever the number of combined drugs
* HIV-RNA plasma VL ≤ 50 copies/mL during the last 24 months prior to screening visit (Week-6/Week-4), documented by at least 4 time-points with no more than one blip in HIV-RNA plasma viral load between 51 and 200 copies/mL
* HIV-RNA plasma VL ≤ 50 copies/mL at screening visit (Week-6/Week-4)
* A genotype is available (on amplified DNA at Week-6/Week-4 Visit and/or on RNA in the medical history of the patient) and shows a virus sensitive to ETR OR no genotype is available (amplification failure on DNA at Week-6/Week-4 Visit and no genotype in the medical history of the patient), there are no virological failure on NNRTI in the medical history
* CD4+ lymphocytes \> 200 cells/mm3
* Creatinine \< 2.5 x ULN
* CPK (Creatine Phospho Kinase) \< 6 ULN (Upper Limit of Normal)
* AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) \< 5 ULN
* Hemoglobin \> 10 g/dL
* Platelets \> 100 000/mm3
* Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential
* For French participants only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme), article L1121-11 of the Public health code
* Patients with a coverage from a social health
* Signed informed consent

Exclusion Criteria:

* Previous exposure to raltegravir or etravirine
* Presence of any documented integrase inhibitor mutation on DNA genotype at Week-6/Week-4 and/or on RNA in the medical history of the patient
* Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac
* HIV-2 infection
* Active viral hepatitis C requiring a specific treatment during the 24 months of the trial
* Patient with a history of non-compliance or irregular follow-up
* Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or antidiabetic treatment within the last 3 months prior the screening visit (Week-6 /Week-4)
* Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John's wort, Carbamazepine (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra™), Triazolam (Halcion®)
* Concomitant treatment using interferon, interleukins or any other immunotherapy or chemotherapy
* Concomitant prophylactic or curative treatment for an opportunistic infection
* All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance
* Subjects under judicial protection due to temporarily and slightly diminished mental or physical faculties, or under legal guardianship
* Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase
* Pregnant women or breastfeeding women

**Minimum Age:** 45 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bobigny

**Country:** France

**Facility:** Hôpital Avicenne

**Zip:** 93000

**Location 2:**

**City:** Bondy

**Country:** France

**Facility:** Hôpital Jean Verdier

**Zip:** 93140

**Location 3:**

**City:** Bordeaux

**Country:** France

**Facility:** Hôpital Saint André

**Zip:** 33076

**Location 4:**

**City:** Le Kremlin Bicêtre

**Country:** France

**Facility:** Hôpital Bicêtre

**Zip:** 94275

**Location 5:**

**City:** Lyon

**Country:** France

**Facility:** Hôpital Croix Rousse

**Zip:** 69317

**Location 6:**

**City:** Marseille

**Country:** France

**Facility:** Hôpital Sainte marguerite

**Zip:** 13009

**Location 7:**

**City:** Montpellier

**Country:** France

**Facility:** Hôpital Gui de Chauliac

**Zip:** 34000

**Location 8:**

**City:** Nantes

**Country:** France

**Facility:** CHU Hôtel Dieu

**Zip:** 44093

**Location 9:**

**City:** Nice

**Country:** France

**Facility:** Hôpital de l'Archet

**Zip:** 06202

**Location 10:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Saint Louis

**Zip:** 75010

**Location 11:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Pitié-Salpétrière

**Zip:** 75013

**Location 12:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Cochin

**Zip:** 75014

**Location 13:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Necker

**Zip:** 75015

**Location 14:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Bichat Claude Bernard

**Zip:** 75018

**Location 15:**

**City:** Paris

**Country:** France

**Facility:** Hôpital Européen Georges Pompidou

**Zip:** 75908

**Location 16:**

**City:** Tours

**Country:** France

**Facility:** Hôpital Bretonneau

**Zip:** 37044

**Location 17:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital de Bellvitge

**Zip:** 08000

**Location 18:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital de la santa Creu i San Pau

**Zip:** 08025

**Location 19:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Clinic

**Zip:** 08036

#### Overall Officials

**Official 1:**

**Affiliation:** Service des Maladies Infectieuses et Tropicales, Groupe Hospitalier Pitié-Salpêtrière, Paris, France

**Name:** Christine Katlama, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Département des Maladies Infectieuses et Tropicales Hôpital Gui de Chauliac, CHU de Montpellier France

**Name:** Jacques Reynes, MD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Inserm UMR S 1136 Université Pierre et Marie Curie Epidémiologie, stratégies thérapeutiques et virologie cliniques dans l'infection à VIH, Paris, France

**Name:** Dominique Costagliola, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.anrs.fr/

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-03-06

- Filename: Prot_SAP_ICF_000.pdf

- Has ICF: True

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Study protocol, Statistical Analysis

- Size: 3066298

- Type Abbrev: Prot_SAP_ICF

- Upload Date: 2020-06-28T08:36

- Date: 2020-01-05

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form: Informed Consent Form

- Size: 381267

- Type Abbrev: ICF

- Upload Date: 2021-01-05T10:35

## Derived Section

### 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: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000019428

- Term: HIV Integrase Inhibitors

- ID: D000019429

- Term: Integrase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018894

- Term: Reverse Transcriptase Inhibitors

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: M333

- Name: Raltegravir Potassium

- Relevance: HIGH

- As Found: Adaptive

- ID: M339955

- Name: Etravirine

- Relevance: HIGH

- As Found: CPET

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21386

- Name: Integrase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M21385

- Name: HIV Integrase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20935

- Name: Reverse Transcriptase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068898

- Term: Raltegravir Potassium

- ID: C000451734

- Term: Etravirine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Raltegravir and Etravirine

**Deaths Num At Risk:** 165

**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.

**ID:** EG000

**Other Num Affected:** 23

**Other Num at Risk:** 165

**Serious Number Affected:** 26

**Serious Number At Risk:** 165

**Title:** Raltegravir and Etravirine

**Frequency Threshold:** 1

#### Other Events

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Diarrhea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Drowsiness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** dysgeusia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Prostatitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 165

**Num Events:** 3

**Term:** Stroke

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 165

**Num Events:** 2

**Term:** Hospitalization further diagnosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 165

**Num Events:** 2

**Term:** Arthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Delirious

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Hepatic cytolysis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Hyperglycemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Loss of teeth

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Open wound of back

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Osteoarthrosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Parotidectomy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Post herpetic neuralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Acute coronary syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Anal abcess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** AST increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Lumbago

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Myocardial infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Pulmonary carcinomia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Sciatica

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Term:** Surgery

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 165

**Num Events:** 1

**Time Frame:** Adverse events data were collected from baseline to week 48 and 96

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 165

**Units:** Participants

### Group

**ID:** BG000

**Title:** Raltegravir and Etravirine

**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 48

**Upper Limit:** 58

**Value:** 52

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 48

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 117

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 124

**Class Title:** Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 24

**Class Title:** Sub-saharan Africa

#### Measurement

**Group ID:** BG000

**Value:** 17

**Class Title:** Others

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 66

**Class Title:** Men who have Sex with Men

#### Measurement

**Group ID:** BG000

**Value:** 72

**Class Title:** Heterosexual

#### Measurement

**Group ID:** BG000

**Value:** 27

**Class Title:** Others/Unknown

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 12.8

**Upper Limit:** 24.2

**Value:** 19.8

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 36

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 93

**Upper Limit:** 286

**Value:** 209

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 11.1

**Upper Limit:** 19

**Value:** 16.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 3.4

**Upper Limit:** 9.3

**Value:** 6.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 32

**Upper Limit:** 89

**Value:** 58

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 120

**Class Title:** once daily

#### Measurement

**Group ID:** BG000

**Value:** 45

**Class Title:** twice daily

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 107

**Class Title:** 2NRTIs + PI/r

#### Measurement

**Group ID:** BG000

**Value:** 11

**Class Title:** NNRTI + PI/r

#### Measurement

**Group ID:** BG000

**Value:** 35

**Class Title:** PI/r

#### Measurement

**Group ID:** BG000

**Value:** 12

**Class Title:** Others

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Class Title:** Cardiovascular

#### Measurement

**Group ID:** BG000

**Value:** 53

**Class Title:** Dyslipidemia

#### Measurement

**Group ID:** BG000

**Value:** 45

**Class Title:** High blood pressure

#### Measurement

**Group ID:** BG000

**Value:** 10

**Class Title:** Diabetes

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 60

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 31

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 525

**Upper Limit:** 904

**Value:** 700

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 525

**Upper Limit:** 966

**Value:** 678

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 0.67

**Upper Limit:** 1.33

**Value:** 0.94

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 4.6

**Upper Limit:** 6.1

**Value:** 5.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 3.4

**Upper Limit:** 4.6

**Value:** 3.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 2.7

**Upper Limit:** 3.8

**Value:** 3.2

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 1.1

**Upper Limit:** 1.6

**Value:** 1.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 1.0

**Upper Limit:** 2.1

**Value:** 1.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 0.6

**Upper Limit:** 1.8

**Value:** 1.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 4.7

**Upper Limit:** 5.7

**Value:** 5.2

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 79.2

**Upper Limit:** 103.2

**Value:** 93.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 22.5

**Upper Limit:** 26.6

**Value:** 24.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 84

**Upper Limit:** 99

**Value:** 92

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 90

**Upper Limit:** 99

**Value:** 95

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 0.9

**Upper Limit:** 1.03

**Value:** 0.97

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 18

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Transmission group
**Unit of Measure:** Participants
### Measure 5
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Time since HIV diagnosis
**Unit of Measure:** years
### Measure 6
**Description:** number of patients with Prior AIDS event
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** CDC stage C
**Unit of Measure:** Participants
### Measure 7
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** CD4 nadir cell count
**Unit of Measure:** cells/mm^3
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Hepatitis C co-infection
**Unit of Measure:** Participants
### Measure 9
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Antiretroviral treatment (ART) duration
**Unit of Measure:** years
### Measure 10
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Duration of suppressed HIV viremia (<50 copies/ml),
**Unit of Measure:** years
### Measure 11
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Duration of last combined antiretroviral therapy (cART)
**Unit of Measure:** Months
### Measure 12
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Antiretroviral treatment daily dosing
**Unit of Measure:** Participants
### Measure 13
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** cART at screening
**Unit of Measure:** Participants
### Measure 14
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Comorbidities
**Unit of Measure:** Participants
### Measure 15
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Active smoking
**Unit of Measure:** Participants
### Measure 16
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Former smokers
**Unit of Measure:** Participants
### Measure 17
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Alcohol use (>2 glasses/day)
**Unit of Measure:** Participants
### Measure 18
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** CD4 cell count at screening
**Unit of Measure:** cells/mm^3
### Measure 19
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** CD8 cell count at screening
**Unit of Measure:** cells/mm^3
### Measure 20
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** CD4/CD8 ratio at screening
**Unit of Measure:** ratio
### Measure 21
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Total cholesterol
**Unit of Measure:** mmol/L
### Measure 22
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Non-HDL cholesterol
**Unit of Measure:** mmol/L
### Measure 23
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** LDL cholesterol
**Unit of Measure:** mmol/L
### Measure 24
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** HDL cholesterol
**Unit of Measure:** mmol/L
### Measure 25
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Triglycerides
**Unit of Measure:** mmol/L
### Measure 26
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Triglycerides/HDL ratio
**Unit of Measure:** ratio
### Measure 27
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Glycaemia
**Unit of Measure:** mmol/L
### Measure 28
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Estimated glomerular filtration rate (eGFR, CKD-EPI method)
**Unit of Measure:** mL/min/1.73 m^2
### Measure 29
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Body Mass Index (BMI)
**Unit of Measure:** kg/m^2
### Measure 30
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Waist circumference
**Unit of Measure:** cm
### Measure 31
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Hip circumference
**Unit of Measure:** cm
### Measure 32
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Waist/Hip ratio
**Unit of Measure:** ratio
### Measure 33
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Viruses with mutations that could potentially impact etravirine
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** The absence of a comparator arm, which in terms of impact on fat, bone density and inflammation/activation markers may limit the interpretation of the observed changes over time. One limitation is the small number of women.
### Point of Contact
**Email:** lambert.assoumou@iplesp.upmc.fr
**Organization:** Inserm, Sorbonne Universite, IPLESP
**Phone:** 0142164280
**Title:** Dr Lambert Assoumou
## 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
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.6
- **Spread:** 
- **Upper Limit:** 99.9
- **Value:** 99.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 95.0
- **Spread:** 
- **Upper Limit:** 99.7
- **Value:** 98.7
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 90.5
- **Spread:** 
- **Upper Limit:** 97.5
- **Value:** 95.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 87.5
- **Spread:** 
- **Upper Limit:** 95.8
- **Value:** 92.7
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.7
- **Spread:** 
- **Upper Limit:** 8.5
- **Value:** 4.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.9
- **Spread:** 
- **Upper Limit:** 10.9
- **Value:** 6.1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2.2
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.01
- **Spread:** 
- **Upper Limit:** 3.3
- **Value:** 0.6
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 96
- **Value:** 96
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.01
- **Spread:** 
- **Upper Limit:** 3.3
- **Value:** 0.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:** 
- **Upper Limit:** 2.2
- **Value:** 0
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.4
- **Spread:** 
- **Upper Limit:** 10.1
- **Value:** 3.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.5
- **Spread:** 
- **Upper Limit:** 85.1
- **Value:** 11.3
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -29
- **Spread:** 
- **Upper Limit:** 111
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -37
- **Spread:** 
- **Upper Limit:** 45
- **Value:** 0
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -10.9
- **Spread:** 
- **Upper Limit:** 16.6
- **Value:** 1.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -18.7
- **Spread:** 
- **Upper Limit:** 16.6
- **Value:** -1.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.7
- **Spread:** 
- **Upper Limit:** 13.8
- **Value:** 5.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -9.4
- **Spread:** 
- **Upper Limit:** 18.9
- **Value:** 5.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -17.1
- **Spread:** 
- **Upper Limit:** 11.2
- **Value:** -5.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.6
- **Spread:** 
- **Upper Limit:** 21.9
- **Value:** 7.4
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 154
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 165
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 165
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 108
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 156
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 156
**Units:** Participants
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -40.2
- **Spread:** 
- **Upper Limit:** 10.4
- **Value:** -18.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 163
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -16.3
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** -0.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 163
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -7.1
- **Spread:** 
- **Upper Limit:** 21.6
- **Value:** 5.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 162
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -19.2
- **Spread:** 
- **Upper Limit:** 10.2
- **Value:** -4.3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 155
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -7.0
- **Spread:** 
- **Upper Limit:** 10.0
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 163
**Units:** Participants
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -22.9
- **Spread:** 
- **Upper Limit:** 37.7
- **Value:** 1.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -21.3
- **Spread:** 
- **Upper Limit:** 45.7
- **Value:** 9.7
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.6
- **Spread:** 
- **Upper Limit:** 4.2
- **Value:** -0.6
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.0
- **Spread:** 
- **Upper Limit:** 24.2
- **Value:** 12.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.7
- **Spread:** 
- **Upper Limit:** 27.8
- **Value:** 11.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.9
- **Spread:** 
- **Upper Limit:** 23.3
- **Value:** 12.2
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.1
- **Spread:** 
- **Upper Limit:** 2.8
- **Value:** 0.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 81
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.9
- **Spread:** 
- **Upper Limit:** 1.8
- **Value:** -1.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 80
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.9
- **Spread:** 
- **Upper Limit:** 1.9
- **Value:** 0.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.8
- **Spread:** 
- **Upper Limit:** 1.3
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 79
**Units:** Participants
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -32.4
- **Spread:** 
- **Upper Limit:** 58.8
- **Value:** 0.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 144
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -23.9
- **Spread:** 
- **Upper Limit:** 16.5
- **Value:** -8.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 158
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -21.0
- **Spread:** 
- **Upper Limit:** 20.5
- **Value:** 0.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 158
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -38
- **Spread:** 
- **Upper Limit:** -8
- **Value:** -27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 158
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.8
- **Spread:** 
- **Upper Limit:** 4.8
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 158
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -34.2
- **Spread:** 
- **Upper Limit:** 55.9
- **Value:** 0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 124
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.6
- **Spread:** 
- **Upper Limit:** 40.7
- **Value:** 16.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 135
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -16.0
- **Spread:** 
- **Upper Limit:** 42.5
- **Value:** 4.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 145
**Units:** Participants
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 77
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 155
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 155
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 139
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 155
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 146
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 146
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 123
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 146
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 136
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 136
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 115
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 136
**Units:** Participants
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.075
- **Spread:** 
- **Upper Limit:** 0.290
- **Value:** 0.172
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.008
- **Spread:** 
- **Upper Limit:** 0.012
- **Value:** 0.009
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.008
- **Spread:** 
- **Upper Limit:** 0.0095
- **Value:** 0.009
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.034
- **Spread:** 
- **Upper Limit:** 0.400
- **Value:** 0.152
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.006
- **Spread:** 
- **Upper Limit:** 0.010
- **Value:** 0.008
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.004
- **Spread:** 
- **Upper Limit:** 0.007
- **Value:** 0.005
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 22
**Units:** Participants
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -18.9
- **Spread:** 
- **Upper Limit:** 15.3
- **Value:** 3.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.1
- **Spread:** 
- **Upper Limit:** 10.9
- **Value:** 3.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -13.7
- **Spread:** 
- **Upper Limit:** 14.2
- **Value:** -2.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 22
**Units:** Participants
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -7.99
- **Spread:** 
- **Upper Limit:** 15.88
- **Value:** 6.62
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.38
- **Spread:** 
- **Upper Limit:** 17.77
- **Value:** 6.91
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -15.81
- **Spread:** 
- **Upper Limit:** 2.38
- **Value:** -11.35
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -20.13
- **Spread:** 
- **Upper Limit:** 27.13
- **Value:** 5.52
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -13.10
- **Spread:** 
- **Upper Limit:** 22.08
- **Value:** 5.62
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -19.77
- **Spread:** 
- **Upper Limit:** -0.07
- **Value:** -6.58
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.90
- **Spread:** 
- **Upper Limit:** 27.79
- **Value:** 18.47
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 16.77
- **Spread:** 
- **Upper Limit:** 42.86
- **Value:** 27.74
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -11.35
- **Spread:** 
- **Upper Limit:** 9.92
- **Value:** -4.84
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -28.10
- **Spread:** 
- **Upper Limit:** 27.57
- **Value:** 5.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -45.18
- **Spread:** 
- **Upper Limit:** -13.70
- **Value:** -38.37
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -33.12
- **Spread:** 
- **Upper Limit:** 16.67
- **Value:** -0.99
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -39.2
- **Spread:** 
- **Upper Limit:** -5.4
- **Value:** -31.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -43.2
- **Spread:** 
- **Upper Limit:** -23.4
- **Value:** -32.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -36.5
- **Spread:** 
- **Upper Limit:** -3.6
- **Value:** -18.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -9.7
- **Spread:** 
- **Upper Limit:** 32.3
- **Value:** 10.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -9.2
- **Spread:** 
- **Upper Limit:** 34.2
- **Value:** 15.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -21.0
- **Spread:** 
- **Upper Limit:** 49.0
- **Value:** 4.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -36.0
- **Spread:** 
- **Upper Limit:** 31.5
- **Value:** 5.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -63.3
- **Spread:** 
- **Upper Limit:** 122.6
- **Value:** 31.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -44.7
- **Spread:** 
- **Upper Limit:** 19.0
- **Value:** -31.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -18.3
- **Spread:** 
- **Upper Limit:** 27.2
- **Value:** 6.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.6
- **Spread:** 
- **Upper Limit:** 90.2
- **Value:** 34.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -7.9
- **Spread:** 
- **Upper Limit:** 46.9
- **Value:** 23.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 5
- **Group ID:** OG002
- **Value:** 19
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.3
- **Spread:** 
- **Upper Limit:** 3.7
- **Value:** 0.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -9.9
- **Spread:** 
- **Upper Limit:** 4.2
- **Value:** 1.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -7.8
- **Spread:** 
- **Upper Limit:** 3.4
- **Value:** -1.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -21.6
- **Spread:** 
- **Upper Limit:** 62.7
- **Value:** 5.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -50.5
- **Spread:** 
- **Upper Limit:** -20.8
- **Value:** -49.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -40.7
- **Spread:** 
- **Upper Limit:** 38.9
- **Value:** -0.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 5
- **Group ID:** OG002
- **Value:** 20
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -37.3
- **Spread:** 
- **Upper Limit:** -2.9
- **Value:** -18.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -8.2
- **Spread:** 
- **Upper Limit:** 33.1
- **Value:** 8.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -34.9
- **Spread:** 
- **Upper Limit:** 31.1
- **Value:** -5.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -48.6
- **Spread:** 
- **Upper Limit:** -0.4
- **Value:** -29.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -7.9
- **Spread:** 
- **Upper Limit:** 50.0
- **Value:** 30.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -14.0
- **Spread:** 
- **Upper Limit:** 32.8
- **Value:** 11.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 21
**Units:** Participants
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.49
- **Spread:** 
- **Upper Limit:** 2.59
- **Value:** -0.96
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.00
- **Spread:** 
- **Upper Limit:** 12.20
- **Value:** 5.69
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -1.10
- **Spread:** 
- **Upper Limit:** 5.17
- **Value:** 2.07
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.64
- **Spread:** 
- **Upper Limit:** 11.71
- **Value:** 7.06
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.16
- **Spread:** 
- **Upper Limit:** 8.85
- **Value:** 2.80
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -0.94
- **Spread:** 
- **Upper Limit:** 6.19
- **Value:** 3.09
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 17
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.76
- **Spread:** 
- **Upper Limit:** 6.54
- **Value:** 2.74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.80
- **Spread:** 
- **Upper Limit:** 15.85
- **Value:** 4.20
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 1.11
- **Spread:** 
- **Upper Limit:** 8.20
- **Value:** 6.52
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 17
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.63
- **Spread:** 
- **Upper Limit:** -1.17
- **Value:** -3.43
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.42
- **Spread:** 
- **Upper Limit:** 10.54
- **Value:** 0.02
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -1.17
- **Spread:** 
- **Upper Limit:** 5.29
- **Value:** 1.85
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 7
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 17
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.84
- **Spread:** 
- **Upper Limit:** 1.94
- **Value:** -2.94
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.62
- **Spread:** 
- **Upper Limit:** 16.91
- **Value:** 6.74
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -0.03
- **Spread:** 
- **Upper Limit:** 28.22
- **Value:** 10.89
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -12.91
- **Spread:** 
- **Upper Limit:** -2.27
- **Value:** -6.90
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10.32
- **Spread:** 
- **Upper Limit:** 25.31
- **Value:** 18.80
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 5.96
- **Spread:** 
- **Upper Limit:** 39.40
- **Value:** 21.27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -8.93
- **Spread:** 
- **Upper Limit:** -2.13
- **Value:** -2.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.35
- **Spread:** 
- **Upper Limit:** 17.91
- **Value:** 16.77
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 0.61
- **Spread:** 
- **Upper Limit:** 31.63
- **Value:** 24.39
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.89
- **Spread:** 
- **Upper Limit:** 0.96
- **Value:** -0.70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.73
- **Spread:** 
- **Upper Limit:** 6.21
- **Value:** 2.13
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -2.91
- **Spread:** 
- **Upper Limit:** 1.93
- **Value:** -1.44
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.60
- **Spread:** 
- **Upper Limit:** 2.54
- **Value:** -0.79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.93
- **Spread:** 
- **Upper Limit:** 20.75
- **Value:** 5.53
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -6.20
- **Spread:** 
- **Upper Limit:** -0.34
- **Value:** -3.24
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.93
- **Spread:** 
- **Upper Limit:** 1.14
- **Value:** -1.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.02
- **Spread:** 
- **Upper Limit:** 8.12
- **Value:** 5.83
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** -4.14
- **Spread:** 
- **Upper Limit:** 2.94
- **Value:** -3.01
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 9
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.

The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** at week48 and at week 96
**Title:** Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96
**Type:** PRIMARY
**Unit of Measure:** percentage of participant
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 2
**Description:** Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) \> 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** weeks 48 and 96
**Title:** Percentage of Patients With Therapeutic Success at Week 48 and Week 96
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 3
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** weeks 48 and 96
**Title:** Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96
**Type:** SECONDARY
**Unit of Measure:** percentage of participant
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 4
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** weeks 48 and 96
**Title:** Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 5
**Description:** Time between the date of the study treatment initiation and the date of virological failure
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** week 96
**Title:** Median Time of Virological Failure
**Type:** SECONDARY
**Unit of Measure:** weeks
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 6
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** weeks 48 and 96
**Title:** Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 7
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** week 96
**Title:** Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 8
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** week 96
**Title:** Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL
**Type:** SECONDARY
**Unit of Measure:** hazard ratio
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 9
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** from day 0 to week 48 and week 96
**Title:** Evolution of Total Cell-associated HIV-DNA
**Type:** SECONDARY
**Unit of Measure:** percentage of change
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 10
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** from day 0 to week 48 and week 96
**Title:** Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
**Type:** SECONDARY
**Unit of Measure:** percentage of change
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 11
**Description:** Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** After week 48, only 156 participants remained on the study treatment
**Reporting Status:** POSTED
**Time Frame:** From day 0 to week 48 and week 96
**Title:** Number of Participants Experiencing Adverse Events and Effects
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 12
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** the number analyzed in one or more rows differs from overall number analyzed due to the Non determined data
**Reporting Status:** POSTED
**Time Frame:** from day 0 to week 96
**Title:** Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
**Type:** SECONDARY
**Unit of Measure:** percentage of change
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 13
**Description:** The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.

Median percent change expressed as median (interquartile range (IQR))
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** the number of analyzed participants differs from overall participants due to the Non determined data.
**Reporting Status:** POSTED
**Time Frame:** from day 0 to week 48 and at week 96
**Title:** Evolution of the Calibrated 5-year Framingham Risk Score
**Type:** SECONDARY
**Unit of Measure:** Median percent change as median (IQR)
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 14
**Description:** Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** from day 0 to week 96
**Title:** Percent Change of Renal Function
**Type:** SECONDARY
**Unit of Measure:** Median percent change, as median (IQR)
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 15
**Description:** Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Five participants were not evaluated at week 96
**Reporting Status:** POSTED
**Time Frame:** from day 0 to week 96
**Title:** Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)
**Type:** SECONDARY
**Unit of Measure:** percentage of change
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 16
**Description:** • Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)

* Lumbar spine BMD, mg/cm2
* Total hip BMD, mg/cm2
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The number analyzed in one or more rows differs from overall number analyzed due to the missing data
**Reporting Status:** POSTED
**Time Frame:** from day 0, to week 48 and week 96
**Title:** Sub-study: Bone Mineral Density
**Type:** SECONDARY
**Unit of Measure:** percentage of change
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 17
**Description:** • Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** week 48
**Title:** Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 18
**Description:** • Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** The number analyzed in one or more rows differs from overall number analyzed due to the missing data
**Reporting Status:** POSTED
**Time Frame:** from day 0 to week 96
**Title:** Inflammatory Parameters
**Type:** SECONDARY
**Unit of Measure:** percentage of change
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 19
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** day 0 and weeks 48 and 96
**Title:** Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 20
**Description:** The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Among 165 analyzed participated, 155 filled the baseline self-reported adherence questionnaire, 146 at week 48 and 136 at week 96
**Reporting Status:** POSTED
**Time Frame:** at week 0, week 48, and week 96
**Title:** Percentage of Participants Compliant With Treatment Program.
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 21
**Description:** We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48)
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** We evaluated the AMH level in 40 women with available samples.
**Reporting Status:** POSTED
**Time Frame:** from day 0, to week 48
**Title:** Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 22
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** We evaluated the MCP1 level in 40 women with available samples.
**Reporting Status:** POSTED
**Time Frame:** from day 0, to week 48
**Title:** Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples
**Type:** SECONDARY
**Unit of Measure:** Percentage change
##### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** OG000
**Title:** Raltegravir and Etravirine
#### Outcome Measure 23
**Description:** Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.

Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.

Ovarian reserve measure is AMH
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** We evaluated the AMH level in 40 women with available samples
**Reporting Status:** POSTED
**Time Frame:** from day 0, to week 96
**Title:** Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
**Type:** SECONDARY
**Unit of Measure:** Percentage of change
##### Group
**Description:** AMH was detectable (level \>0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity
**ID:** OG000
**Title:** Premenopausal With Mesurable AMH
##### Group
**Description:** AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
**ID:** OG001
**Title:** Premenopausal With Reduced Ovarian Reserve
##### Group
**Description:** The menopausal status was recorded by the questionnaire at inclusion
**ID:** OG002
**Title:** Postmenopausal
#### Outcome Measure 24
**Description:** BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** AMH level were evaluated in 40 women with available samples
**Reporting Status:** POSTED
**Time Frame:** from day 0, to week 96
**Title:** Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
**Type:** SECONDARY
**Unit of Measure:** Percentage of change
##### Group
**Description:** AMH was detectable (level \>0.06 ng/ml) indicating that they had an ovarian reserve and a status of reproductive activity
**ID:** OG000
**Title:** Premenopausal With Mesurable AMH
##### Group
**Description:** AMH\<0.02 ng/ml at inclusion in non-menopausal women who were classified as pre-menopausal
**ID:** OG001
**Title:** Premenopausal With Reduced Ovarian Reserve
##### Group
**Description:** The menopausal status was recorded by the questionnaire at inclusion
**ID:** OG002
**Title:** Postmenopausal
### Participant Flow Module
#### Group
**Description:** raltegravir and etravirine: Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.

Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.
**ID:** FG000
**Title:** Raltegravir and Etravirine
#### Period
**Title:** From Baseline to Week 48
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 165
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 156
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
#### Period
**Title:** From Week 48 to Week 96
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 156
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 152
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
**Pre-Assignment Details:** Five patients did not initiate the trial treatment by their own decision, leaving 165 patients for the analysis.
**Recruitment Details:** Between January and November 2015, 219 patients from 20 sites were screened and 170 patients were enrolled in the study.
**Has Results:** True