Observational Study of HIV-Infected Subjects With X4-Tropic or Non-Phenotypeable Virus

Stopped early

Conditions studied: HIV Infection

In brief

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 investigational treatment will be administered through this study.

Key facts

Study ID

NCT00321438

Run by

GlaxoSmithKline

People needed

150

Starts

2005-07-01

Last updated by the study team

2009-05-18

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.
• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Tarzana, California, United States
• GSK Investigational Site — Washington D.C., District of Columbia, 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 — 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 — Baltimore, Maryland, United States
• GSK Investigational Site — East Orange, New Jersey, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Hampton, Virginia, United States

Full record on ClinicalTrials.gov

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