Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

Completed · Phase 4

Conditions studied: HIV Infection

In brief

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.

Key facts

Study ID

NCT00038506

Run by

ViiV Healthcare

People needed

100

Starts

2002-03-01

Expected to finish

2004-08-01

Last updated by the study team

2015-04-08

Who can join

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

You may qualify if…

• Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
• Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
• Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
• A CD4+ lymphocyte count less than or equal to 100.

You may not qualify if…

• Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
• Have not had an AIDS defining illness within 30 days of screen.
• Pregnant or breast-feeding.
• Specified viral genotypes upon screening.
• And other inclusion or exclusion criteria to be evaluated by the physician.

Where it is running

• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Rafael, California, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Lake Worth, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami Beach, Florida, United States
• GSK Investigational Site — North Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Tallahassee, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Maywood, Illinois, United States
• GSK Investigational Site — Lafayette, Indiana, United States
• GSK Investigational Site — Berkeley, Michigan, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Valhalla, New York, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States
• GSK Investigational Site — Arlington, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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