Overview

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

Status:
Terminated
Trial end date:
2007-09-11
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-tropic virus
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Treatments:
Aplaviroc
Criteria
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.