Clinical Trials

MainTitle

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
Hoffmann-La Roche


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002397

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1998
History of Changes
Purpose

Purpose

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

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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

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 ClinicalTrials.gov identifier: NCT00002397

Locations

United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029

Sponsors and Collaborators

Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT00002397   History of Changes  
Other Study ID Numbers: 229P  
  NR15690/M61021  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Kidney Failure, Chronic
HIV-1
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Lamivudine
Saquinavir
AIDS-Associated Nephropathy
Reverse Transcriptase Inhibitors
Viral Load
Nelfinavir

Additional relevant MeSH terms:
HIV Infections
Kidney Diseases
AIDS-Associated Nephropathy
Lamivudine
Stavudine
Nelfinavir
Saquinavir

ClinicalTrials.gov processed this data on December 18, 2017
This information is provided by ClinicalTrials.gov.