Back to resultsA Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
Primary Purpose
HIV Infections, AIDS-Associated Nephropathy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir mesylate
Saquinavir
Lamivudine
Stavudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Kidney Failure, Chronic, HIV-1, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, AIDS-Associated Nephropathy, Reverse Transcriptase Inhibitors, Viral Load, Nelfinavir
Eligibility 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.
Sites / Locations
- Mount Sinai Med Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002397
Brief Title
A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
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 Type
Interventional
2. Study Status
Record Verification Date
December 1998
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS-Associated Nephropathy
Keywords
Kidney Failure, Chronic, HIV-1, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, AIDS-Associated Nephropathy, Reverse Transcriptase Inhibitors, Viral Load, Nelfinavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Saquinavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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