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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

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

Condition Intervention Phase
HIV Infections AIDS-Associated Nephropathy Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Lamivudine Drug: Stavudine Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 24
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Patients must have:

  • Detectable HIV-1 RNA by Amplicor assay.
  • Biopsy-proven nephropathy.

Exclusion Criteria

Prior Medication:


  • Saquinavir and nelfinavir.
  • d4T or 3TC within the past 4 months.


Stable antiretroviral therapy for more than 4 weeks.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002397

United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
Sponsors and Collaborators
Hoffmann-La Roche
  More Information Identifier: NCT00002397     History of Changes
Other Study ID Numbers: 229P
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Kidney Failure, Chronic
Drug Therapy, Combination
HIV Protease Inhibitors
AIDS-Associated Nephropathy
Reverse Transcriptase Inhibitors
Viral Load

Additional relevant MeSH terms:
HIV Infections
Kidney Diseases
AIDS-Associated Nephropathy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Urologic Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on September 20, 2017