A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients

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

Keywords

ClinConnect Summary

A number of studies both within and outside the ACTG have been initiated or are in development to try to address the issue of alternative treatments for patients who either do not achieve or lose virologic control while receiving protease inhibitors (PIs). Amprenavir (APV) is an attractive candidate to investigate as part of salvage regimens because: 1) it has substantial antiretroviral activity; 2) there are preliminary in vitro and in vivo data that suggest that resistance to this agent may be mediated in part by a unique mutation (I50V); and 3) its cross-resistance profile to the approve...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this study if they:
• • Are HIV-positive.
• • Have current virologic failure (2 consecutive HIV blood levels above 1,000 copies/ml) while on PIs.
• • Are over 13 years of age (consent of parent or guardian required if under 18).
• • Agree to practice abstinence or use effective methods of birth control during the study and for 90 days after.
• • Exclusion Criteria
• Patients will not be eligible for this study if they:
• • Have hepatitis within 90 days prior to study entry.
• • Have a history of a peripheral neuropathy within 60 days of study entry.
• • Have an unexplained temperature for a 7-day period.
• • Have chronic diarrhea within 30 days prior to study entry.
• • Have cancer requiring chemotherapy.
• • Received any therapy for infection or other illness within 30 days prior to study entry.
• • Have received certain other medications.
• • Are pregnant or breast-feeding.