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

Stopped early · Phase 3

Conditions studied: Infection, Human Immunodeficiency Virus I

In brief

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

Key facts

Study ID

NCT00197145

Run by

ViiV Healthcare

People needed

24

Starts

2005-07-21

Expected to finish

2007-09-11

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Beverly Hills, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Laguna Beach, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — Glastonbury, Connecticut, United States
• GSK Investigational Site — Norwalk, Connecticut, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Key West, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Oakland Park, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Plantation, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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