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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Current recommendations for the initial treatment of HIV infection have centered on the reduction of plasma HIV levels. It has been shown that a combination of 2 nucleoside reverse transcriptase inhibitors (NRTIs) and a PI is the most effective barriers to disease progression. This study attempts to demonstrate these data.

Two options are available for patients whose initial PI-containing regimen has failed to suppress viral replication.

Option 1 consists of immediate versus deferred use of a nonnucleoside reverse transcriptase inhibitor (NNRTI). Patients who choose Option 1 are randomize...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.

Trial Officials