Status:
TERMINATED
Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus
Lead Sponsor:
GlaxoSmithKline
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to measure viral tropism over time in subjects with X4-tropic or non-phenotypeable virus while receiving standard of care therapy. This is an observational study. No inves...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- HIV-infected.
- Screening viral load at least 5000copies/mL.
- X4-tropic only or non-phenotypeable 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: NRTI, NNRTI, and 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:
- R5-tropic only or R5/X4-tropic virus at screening, changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of observational study.
- Pregnant or breastfeeding women.
- Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, cancer, or severe illness.
- Current use of certain medications may exclude participation in this study.
- Additional qualifying criteria and laboratory test requirements to be determined by study physician.
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00321438
Start Date
July 1 2005
Last Update
May 18 2009
Active Locations (15)
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1
GSK Investigational Site
Los Angeles, California, United States, 90069
2
GSK Investigational Site
Tarzana, California, United States, 91356
3
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20037
4
GSK Investigational Site
Fort Myers, Florida, United States, 33901