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

• Status: Completed
• Trial end date: 2000-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir.

Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Adefovir; Adefovir dipivoxil; Amprenavir; Efavirenz; HIV Protease Inhibitors; Indinavir; Nelfinavir; Protease Inhibitors; Saquinavir

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.