A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease

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

Summary

The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Lamivudine; Nelfinavir; Saquinavir; Stavudine

Criteria

Inclusion Criteria

Patients must have:

• Detectable HIV-1 RNA by Amplicor assay.

• Biopsy-proven nephropathy.

Exclusion Criteria

Prior Medication:

Excluded:

• Saquinavir and nelfinavir.

• d4T or 3TC within the past 4 months.

Required:

Stable antiretroviral therapy for more than 4 weeks.