Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Saquinavir

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Have an HIV count of 5,000 copies/ml or more.

• Have a CD4 count of 100 cells/mm3 or more.

• Meet specific requirements if you have ever taken NRTIs.

• Are 16 - 64 years old (need consent if under 18).

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

Exclusion Criteria

You will not be eligible for this study if you:

• Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.

• Have taken all the available NRTIs.

• Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.

• Have a history of weight loss, muscle pain, and loss of appetite.

• Have taken certain medications, including anti-HIV drugs other than those required by this study.

• Are pregnant or breast-feeding.

• Abuse alcohol or drugs.

• Are unable to complete the study for any reason.