A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; AIDS-Associated Nephropathy
Intervention: Nelfinavir mesylate (Drug); Saquinavir (Drug); Lamivudine (Drug); Stavudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hoffmann-La Roche
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.
Clinical Details
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
Study design: Treatment, Open Label, Safety Study
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Mount Sinai Med Ctr, New York, New York 10029, United States
Additional Information
Last updated: June 23, 2005
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