A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks

Completed · Not applicable

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare different treatments for HIV infection to see which works best to lower HIV levels and to raise the number of CD4 cells (cells of the immune system that fight infection), in HIV-positive individuals who have been on a protease inhibitor-containing drug regimen for at least 16 weeks. Researchers have found that combination anti-HIV therapy (multiple drugs given together) can help prevent AIDS-related illnesses and help people with AIDS live longer. In this study, the anti-HIV drug efavirenz (EFV) will be tested with 1 or 2 other protease inhibitors (PIs) to see which combination works best to treat HIV infection. EFV has been shown to limit the amount of HIV virus produced by infected cells.

Key facts

Study ID

NCT00000914

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

800

Expected to finish

2000-06-01

Last updated by the study team

2021-10-29

Who can join

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

You may qualify if…

• You may be eligible for this study if you:
• Are HIV-positive.
• Have an HIV RNA count of at least 400 copies/ml.
• Are at least 13 years old (need consent if under 18).
• Have been on antiretroviral treatment (including at least 2 NRTIs) for at least 16 weeks prior to study entry.
• Agree to practice abstinence or to use effective methods of birth control, including a barrier method, during the study.

You may not qualify if…

• You will not be eligible for this study if you:
• Are pregnant or breast-feeding.
• Have active opportunistic (HIV-associated) infections.
• Have taken nelfinavir (NFV) for more than 2 weeks after failing indinavir/ritonavir (IDV/RTV) treatment or have taken IDV/RTV for more than 2 weeks after failing NFV treatment.
• Have used any protease inhibitor other than NFV or IDV/RTV for more than 2 weeks.
• Have used any non-nucleoside reverse transcriptase inhibitor (NNRTI) for more than 1 week.

Where it is running

• Community Consortium / UCSF — San Francisco, California, United States
• Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
• Washington Reg AIDS Prog / Dept of Infect Dis — Washington D.C., District of Columbia, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Wayne State Univ - WSU/DMC / Univ Hlth Ctr — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
• North Jersey Community Research Initiative — Newark, New Jersey, United States
• Partners in Research / New Mexico — Albuquerque, New Mexico, United States
• Harlem AIDS Treatment Grp / Harlem Hosp Ctr — New York, New York, United States
• The Research and Education Group — Portland, Oregon, United States
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Richmond AIDS Consortium / Div of Infect Diseases — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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