Brief Summary

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Official Title: "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."

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-tropic virus

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: October 2005

Interventions Used in this Clinical Trial

• Drug: GW873140

Outcome Measures for this Clinical Trial

Primary Measures

• HIV viral load response at 24 and 48 weeks as measured by proportion of subjects with undetectable viral load, change from baseline over time, proportion of subjects with 1.0 log drop, and time to virologic failure.
  • Time Frame: 24 and 48 weeks
    Safety Issue?: Yes

Secondary Measures

• Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes, and adherence will be determined over 24 and 48 weeks. Liver tests will be done every 2 weeks for 24 weeks.
  • Time Frame: 24 and 48 weeks
    Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• HIV-infected.
• Screening viral load at least 5000copies/mL.
• R5-tropic only virus at screening.
• Total prior antiretroviral experience of at least 3 months and 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/X4-tropic, X4-tropic only, or 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • GlaxoSmithKline
• Provider of Information About this Clinical Study
  • Study Director, GSK
• Overall Official(s)
  • GSK Clinical Trials, Ph.D., Study Director, GlaxoSmithKline