A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
|HIV Infections AIDS-Associated Nephropathy||Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Lamivudine Drug: Stavudine||Phase 3|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Exploratory Study of Fortovase (Saquinavir) Soft Gelatin Capsules (SGC) Plus d4T and 3TC or Fortovase (Saquinavir) SGC Plus Nelfinavir and d4T in Patients With HIV-1 Associated Nephropathy|
This is an open-label, non-comparative, randomized, single center, 24-week study. Patients are stratified into 3 groups (8 patients in each group) based on kidney function:
Group 1: Serum creatine less than 2 mg/dL. Group 2: Serum creatine 2-5 mg/dL. Group 3: Serum creatine greater than 5 mg/dL.
All 24 patients are randomized 1:1 to receive 1 of 2 study regimens:
Arm A: Saquinavir SGC plus d4T plus 3TC. Arm B: Saquinavir SGC plus nelfinavir plus d4T. Patients are seen at Weeks 4, 8, 12, and 24. At Week 24, a kidney biopsy is performed with patient consent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002397
|United States, New York|
|Mount Sinai Med Ctr|
|New York, New York, United States, 10029|