Status:
TERMINATED
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-Tropic Treatment-Experienced HIV-Infected Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 su...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00197197
Start Date
July 1 2005
End Date
October 1 2005
Last Update
March 29 2011
Active Locations (12)
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1
GSK Investigational Site
Los Angeles, California, United States, 90046
2
GSK Investigational Site
Norwalk, Connecticut, United States, 06851
3
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
4
GSK Investigational Site
Hollywood, Florida, United States, 33020