A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

• Status: Completed
• Trial end date: 2002-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment.

In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Amprenavir; Didanosine; Efavirenz; Indinavir; Lamivudine; Lamivudine, zidovudine drug combination; Nelfinavir; Ritonavir; Saquinavir; Stavudine; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are over 13 years old (need consent of parent or guardian if under 18).

• Are HIV-positive.

• Currently have virologic failure (more than 1,000 copies of HIV RNA per ml).

• Agree to abstinence or use of effective birth control during the study.

• Have been taking NFV for the past 12 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have a fever for 7 days or diarrhea for 30 days before study entry.

• Have a history of peripheral neuropathy within 60 days of study entry.

• Have hepatitis.

• Have any malignancy (cancer) other than minimal Kaposi's sarcoma.

• Are pregnant or breast-feeding.

• Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry.

• Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days.

• Have received an HIV vaccine 30 days before study entry.

• Are receiving certain other medications.