A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
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|ClinicalTrials.gov Identifier: NCT00002397|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections AIDS-Associated Nephropathy||Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Lamivudine Drug: Stavudine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Masking:||None (Open Label)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002397
|United States, New York|
|Mount Sinai Med Ctr|
|New York, New York, United States, 10029|