Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-Tropic Treatment-Experienced HIV-Infected Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5/X4-tropic virus

Official Title
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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Compare the Efficacy and Safety of GW873140 400mg BID in Combination With a Ritonavir-containing Optimized Background Therapy (OBT) Regimen Versus Placebo Plus OBT Over 48 Weeks.

Conditions
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HIV Infection

Intervention / Treatment
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* Drug: GW873140


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: HIV-infected. Screening viral load at least 5000copies/mL. R5/X4-tropic virus at screening. Total prior antiretroviral experience of at least 3 months. Documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening. Able to receive a ritonavir-boosted protease inhibitor during treatment studies. Women of childbearing potential must use specific forms of contraception. Exclusion criteria: Acute laboratory abnormalities. History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility. R5-tropic only. X4-tropic only. non-phenotypeable virus at screening. Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study. Pregnancy or breastfeeding women. Recent participation in an experimental drug trial. Prior use of a CCR5 or CXCR4 antagonist. Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness. Current use of certain medications may exclude participation in this study. Additional qualifying criteria and laboratory test requirements to be assessed by study physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW873140|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV viral load response at 24 and 48 weeks. |  | 24 and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes.Liver tests will be done every 2 weeks for 24 weeks. |  | every 2 weeks for 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1 GW873140 CCR5 antagonist treatment experienced