A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen

Completed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare the anti-HIV efficacy, safety and effect of serum lipids of two boosted protease inhibitor-based HAART regimens (ARV/RTV v. LPV/RTV) in HIV-1 infected subjects who have experienced their first virologic failure while receiving a NNRTI-containing HAART regimen.

Key facts

Study ID

NCT00135395

Run by

Bristol-Myers Squibb

People needed

200

Starts

2004-05-01

Expected to finish

2006-02-01

Last updated by the study team

2010-02-05

Who can join

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

You may qualify if…

• Patients ≥ 18 years of age infected with HIV
• Plasma HIV RNA ≥ 1000 copies/mL and CD4 cell count ≥ 50 cells/mm3
• Currently receiving a NNRTI-containing HAART regimen or not currently receiving a NNRTI-containing HAART regimen and have not been treated with an alternative regimen since the documented virologic failure (with genotype performed within 2 weeks of the discontinuation of the failing regimen and the genotype report is available)
• The failing NNRTI-containing regimen must be the patient's first virologic failure on treatment and contain a NNRTI and at least 2 NRTIs. The regimen must have been administered for at least 24 weeks and the patient must have documented virologic response to the regimen (HIV RNA < 400 c/mL)

You may not qualify if…

• Pregnancy or breastfeeding
• Reported virologic failure to two or more antiretroviral regimens
• Active AIDS-defined opportunistic infection or disease
• Proven or suspected acute hepatitis within 30 days prior to study entry

Where it is running

• Local Institution — Montgomery, Alabama, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Bakersfield, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — San Francisco, California, United States
• Local Institution — San Mateo, California, United States
• Local Institution — Tarzana, California, United States
• Local Institution — West Hollywood, California, United States
• Local Institution — Norwalk, Connecticut, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Atlantis, Florida, United States
• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Jacksonville, Florida, United States
• Local Institution — Miami, Florida, United States
• Local Institution — Miami Beach, Florida, United States
• Local Institution — North Miami, Florida, United States
• Local Institution — Orlando, Florida, United States
• Local Institution — Plantation, Florida, United States
• Local Institution — Safety Harbor, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — Atlanta, Georgia, United States
• Local Institution — Decatur, Georgia, United States
• Local Institution — Chicago, Illinois, United States
• Local Institution — Hobson City, Alabama, United States

Full record on ClinicalTrials.gov

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