## Protocol Section
### Identification Module
**NCT ID:** NCT00242879

**Brief Title:** A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

**Official Title:** Phase IIB, Randomized, Multicenter, Parallel Group, Study to Evaluate the Safety, Pharmacokinetics and Antiviral Effect of Four Blinded Dosing Regimens of GW640385X/Ritonavir Compared to Open-label Current PI Therapy in HIV-1 Infected, Protease Inhibitor Experienced Adults for 2 Weeks With Long-term Assessment (>48 Weeks) of Safety, Pharmacokinetic and Antiviral Activity of Selected 385/RTV Dosing Regimen(s) vs. a Ritonavir-boosted, Protease Inhibitor Containing Regimen

#### Organization Study ID Info
**ID:** HPR20001
#### Organization
**Class:** INDUSTRY
**Full Name:** ViiV Healthcare
### Status Module
#### Completion Date
**Date:** 2007-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-25

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2007-06

**Type:** ACTUAL

#### Start Date
**Date:** 2005-08

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2005-10-21
**Type:** ESTIMATED
**Study First Submit Date:** 2005-10-19
**Study First Submit QC Date:** 2005-10-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** ViiV Healthcare

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

**Detailed Description:** A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (\>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

### Conditions Module

**Conditions:**

- Infection, Human Immunodeficiency Virus I

- HIV-1 Infection

**Keywords:**

- treatment-experienced

- RTV

- protease inhibitor

- ritonavir

- GW640385

- HIV-1

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 130

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Physician determined comparator PI + ritonavir

**Type:** DRUG

#### Intervention 2

**Name:** GW640385 + ritonavir

**Other Names:**

- Physician determined comparator PI + ritonavir

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Time averaged change in plasma HIV-1 RNA over 16 wks

**Measure:** Proportion of subjects achieving the target pharmacokinetic (PK) GW640385 drug levels

**Measure:** Change in laboratory parameters

#### Secondary Outcomes

**Measure:** Assessments of HIV viral load changes

**Measure:** GW640385 and RTV pharmacokinetic measurements

**Measure:** The incidence of adverse events

**Measure:** Changes in laboratory measurements

**Measure:** ECG measurements

**Measure:** HIV viral resistance assessment

**Measure:** Immunologic measures

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* 18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
* HIV-1 infected subjects.
* Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
* Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.
* Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
* Subjects must have been receiving the same anti-HIV medicines that they are on currently for at least 8 weeks prior to Screening; these anti-HIV medicines will include a single protease inhibitor (PI) in combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.
* Able to understand and follow protocol requirements, instructions and protocol-stated restrictions.
* Be willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

* Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
* Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
* Active CDC Class C disease at screening.
* Pregnant or breastfeeding women.
* Protocol-specified laboratory abnormalities at Screening.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Arizona

**Zip:** 85006

**Location 2:**

**City:** Bakersfield

**Country:** United States

**Facility:** GSK Investigational Site

**State:** California

**Zip:** 93301

**Location 3:**

**City:** Fountain Valley

**Country:** United States

**Facility:** GSK Investigational Site

**State:** California

**Zip:** 92708

**Location 4:**

**City:** Los Angeles

**Country:** United States

**Facility:** GSK Investigational Site

**State:** California

**Zip:** 90046

**Location 5:**

**City:** San Francisco

**Country:** United States

**Facility:** GSK Investigational Site

**State:** California

**Zip:** 94115

**Location 6:**

**City:** San Francisco

**Country:** United States

**Facility:** GSK Investigational Site

**State:** California

**Zip:** 94121

**Location 7:**

**City:** Denver

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Colorado

**Zip:** 80204

**Location 8:**

**City:** Denver

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Colorado

**Zip:** 80220

**Location 9:**

**City:** Norwalk

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Connecticut

**Zip:** 06851

**Location 10:**

**City:** Washington, D.C.

**Country:** United States

**Facility:** GSK Investigational Site

**State:** District of Columbia

**Zip:** 20007

**Location 11:**

**City:** Washington, D.C.

**Country:** United States

**Facility:** GSK Investigational Site

**State:** District of Columbia

**Zip:** 20009

**Location 12:**

**City:** Bradenton

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Zip:** 34205

**Location 13:**

**City:** Fort Lauderdale

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Zip:** 33306

**Location 14:**

**City:** Fort Lauderdale

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Zip:** 33308

**Location 15:**

**City:** Fort Lauderdale

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Zip:** 33316

**Location 16:**

**City:** Miami Beach

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Florida

**Zip:** 33140

**Location 17:**

**City:** Chicago

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Illinois

**Zip:** 60612-7230

**Location 18:**

**City:** Chicago

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Illinois

**Zip:** 60613

**Location 19:**

**City:** Chicago

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Illinois

**Zip:** 60657

**Location 20:**

**City:** Indianapolis

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Indiana

**Zip:** 46202

**Location 21:**

**City:** Louisville

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Kentucky

**Zip:** 40202

**Location 22:**

**City:** Baltimore

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Maryland

**Zip:** 21201

**Location 23:**

**City:** Boston

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Massachusetts

**Zip:** 02118

**Location 24:**

**City:** Boston

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Massachusetts

**Zip:** 02215

**Location 25:**

**City:** Las Vegas

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Nevada

**Zip:** 89102

**Location 26:**

**City:** Newark

**Country:** United States

**Facility:** GSK Investigational Site

**State:** New Jersey

**Zip:** 7102

**Location 27:**

**City:** Rochester

**Country:** United States

**Facility:** GSK Investigational Site

**State:** New York

**Zip:** 14604

**Location 28:**

**City:** Greenville

**Country:** United States

**Facility:** GSK Investigational Site

**State:** South Carolina

**Zip:** 29605

**Location 29:**

**City:** Dallas

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Texas

**Zip:** 75246

**Location 30:**

**City:** Houston

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Texas

**Zip:** 77027

**Location 31:**

**City:** Hampton

**Country:** United States

**Facility:** GSK Investigational Site

**State:** Virginia

**Zip:** 23666

**Location 32:**

**City:** Darlinghurst

**Country:** Australia

**Facility:** GSK Investigational Site

**State:** New South Wales

**Zip:** 2010

**Location 33:**

**City:** Liverpool

**Country:** Australia

**Facility:** GSK Investigational Site

**State:** New South Wales

**Zip:** 2170

**Location 34:**

**City:** South Yarra

**Country:** Australia

**Facility:** GSK Investigational Site

**State:** Victoria

**Zip:** 3141

**Location 35:**

**City:** Bruxelles

**Country:** Belgium

**Facility:** GSK Investigational Site

**Zip:** 1000

**Location 36:**

**City:** Vancouver

**Country:** Canada

**Facility:** GSK Investigational Site

**State:** British Columbia

**Zip:** V6Z 2C7

**Location 37:**

**City:** Toronto

**Country:** Canada

**Facility:** GSK Investigational Site

**State:** Ontario

**Zip:** M4N 3M5

**Location 38:**

**City:** Toronto

**Country:** Canada

**Facility:** GSK Investigational Site

**State:** Ontario

**Zip:** M5B 1L6

**Location 39:**

**City:** Montreal

**Country:** Canada

**Facility:** GSK Investigational Site

**State:** Quebec

**Zip:** H2L 4P9

**Location 40:**

**City:** Montreal

**Country:** Canada

**Facility:** GSK Investigational Site

**State:** Quebec

**Zip:** H2X 2P4

**Location 41:**

**City:** Sainte-Foy

**Country:** Canada

**Facility:** GSK Investigational Site

**State:** Quebec

**Zip:** G1V 4G2

**Location 42:**

**City:** Caen

**Country:** France

**Facility:** GSK Investigational Site

**Zip:** 14000

**Location 43:**

**City:** La Roche Sur Yon cedex 9

**Country:** France

**Facility:** GSK Investigational Site

**Zip:** 85025

**Location 44:**

**City:** Lyon Cedex 02

**Country:** France

**Facility:** GSK Investigational Site

**Zip:** 69288

**Location 45:**

**City:** Lyon Cedex 03

**Country:** France

**Facility:** GSK Investigational Site

**Zip:** 69437

**Location 46:**

**City:** Nantes

**Country:** France

**Facility:** GSK Investigational Site

**Zip:** 44093

**Location 47:**

**City:** Paris Cedex 10

**Country:** France

**Facility:** GSK Investigational Site

**Zip:** 75475

**Location 48:**

**City:** Paris Cedex 12

**Country:** France

**Facility:** GSK Investigational Site

**Zip:** 75571

**Location 49:**

**City:** Muenchen

**Country:** Germany

**Facility:** GSK Investigational Site

**State:** Bayern

**Zip:** 80335

**Location 50:**

**City:** Frankfurt

**Country:** Germany

**Facility:** GSK Investigational Site

**State:** Hessen

**Zip:** 60590

**Location 51:**

**City:** Bonn

**Country:** Germany

**Facility:** GSK Investigational Site

**State:** Nordrhein-Westfalen

**Zip:** 53127

**Location 52:**

**City:** Essen

**Country:** Germany

**Facility:** GSK Investigational Site

**State:** Nordrhein-Westfalen

**Zip:** 45122

**Location 53:**

**City:** Berlin

**Country:** Germany

**Facility:** GSK Investigational Site

**Zip:** 13353

**Location 54:**

**City:** Hamburg

**Country:** Germany

**Facility:** GSK Investigational Site

**Zip:** 20099

**Location 55:**

**City:** Ferrara

**Country:** Italy

**Facility:** GSK Investigational Site

**State:** Emilia-Romagna

**Zip:** 44100

**Location 56:**

**City:** Rimini

**Country:** Italy

**Facility:** GSK Investigational Site

**State:** Emilia-Romagna

**Zip:** 47900

**Location 57:**

**City:** Milano

**Country:** Italy

**Facility:** GSK Investigational Site

**State:** Lombardia

**Zip:** 20127

**Location 58:**

**City:** Pavia

**Country:** Italy

**Facility:** GSK Investigational Site

**State:** Lombardia

**Zip:** 27100

**Location 59:**

**City:** Torino

**Country:** Italy

**Facility:** GSK Investigational Site

**State:** Piemonte

**Zip:** 10149

**Location 60:**

**City:** Bari

**Country:** Italy

**Facility:** GSK Investigational Site

**State:** Puglia

**Zip:** 70124

**Location 61:**

**City:** Bagno a Ripoli (FI)

**Country:** Italy

**Facility:** GSK Investigational Site

**State:** Toscana

**Zip:** 50126

**Location 62:**

**City:** Cascais

**Country:** Portugal

**Facility:** GSK Investigational Site

**Zip:** 2750

**Location 63:**

**City:** Lisboa

**Country:** Portugal

**Facility:** GSK Investigational Site

**Zip:** 1150

**Location 64:**

**City:** Ponce

**Country:** Puerto Rico

**Facility:** GSK Investigational Site

**Zip:** 00731

**Location 65:**

**City:** San Juan

**Country:** Puerto Rico

**Facility:** GSK Investigational Site

**Zip:** 00909-1711

**Location 66:**

**City:** Bucharest

**Country:** Romania

**Facility:** GSK Investigational Site

**Zip:** 021105

**Location 67:**

**City:** Constanta

**Country:** Romania

**Facility:** GSK Investigational Site

**Zip:** 900709

**Location 68:**

**City:** Iasi

**Country:** Romania

**Facility:** GSK Investigational Site

**Zip:** 700116

**Location 69:**

**City:** London

**Country:** United Kingdom

**Facility:** GSK Investigational Site

**Zip:** EC1 7BE

**Location 70:**

**City:** London

**Country:** United Kingdom

**Facility:** GSK Investigational Site

**Zip:** SW10 9TH

#### Overall Officials

**Official 1:**

**Affiliation:** GlaxoSmithKline

**Name:** GSK Clinical Trials, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

- ID: D000086982

- Term: Blood-Borne 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: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- 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: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- 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: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000000163

- Term: Acquired Immunodeficiency Syndrome

- ID: D000015658

- Term: HIV Infections

### Intervention Browse Module - Ancestors

- ID: D000017320

- Term: HIV Protease Inhibitors

- ID: D000084762

- Term: Viral Protease Inhibitors

- ID: D000011480

- Term: Protease Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000065692

- Term: Cytochrome P-450 CYP3A Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21394

- Name: Ritonavir

- Relevance: HIGH

- As Found: Left

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M19609

- Name: HIV Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M14343

- Name: Protease Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M30564

- Name: Cytochrome P-450 CYP3A Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000019438

- Term: Ritonavir

### Misc Info Module

- Version Holder: 2024-05-24
