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

• Status: Terminated
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Aplaviroc

Criteria

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.