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

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

Keywords

ClinConnect Summary

To maximize the likelihood of a favorable response to salvage therapy, 4 or 5 drug regimens should be studied. Regimens containing fewer drugs, particularly those lacking a non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz, are likely to result in an unacceptable rate of virological failure. Therefore, this study examines drug combinations which include two new nucleoside reverse transcriptase inhibitors (NRTIs), the NNRTI efavirenz, and either one or two protease inhibitors which are known not to produce cross-resistance to nelfinavir.

Patients are randomly selected...

Gender

ALL

Eligibility 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.