Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

Completed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.

Key facts

Study ID

NCT00135382

Run by

Bristol-Myers Squibb

People needed

254

Starts

2002-06-01

Expected to finish

2005-10-01

Last updated by the study team

2010-02-17

Who can join

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

You may qualify if…

• Documented HIV infection
• ≥ 18 years of age and weight at least 40kg
• Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
• Patients receiving a PI and ≥ 2 NRTIs

You may not qualify if…

• Pregnancy or breastfeeding
• Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
• Active AIDS-defining opportunistic infection or disease
• Proven or suspected acute hepatitis within 30 days prior to study entry

Where it is running

• Local Institution — Little Rock, Arkansas, United States
• Local Institution — Beverly Hills, California, United States
• Local Institution — Fountain Valley, California, United States
• Local Institution — Long Beach, California, United States
• Local Institution — Los Angeles, California, United States
• Local Institution — San Diego, California, United States
• Local Institution — San Francisco, California, United States
• Local Institution — Tarzana, California, United States
• Local Institution — West Hollywood, California, United States
• Local Institution — Denver, Colorado, 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 — Daytona Beach, 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 — South Miami, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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