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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002397
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002397 on ClinicalTrials.gov Archive Site
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A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • AIDS-Associated Nephropathy
  • Drug: Nelfinavir mesylate
  • Drug: Saquinavir
  • Drug: Lamivudine
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002397
229P, NR15690/M61021
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
December 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP