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	Treatment or Intervention	Phase
HIV Infections AIDS-Associated Nephropathy	Drug: Nelfinavir mesylate  Drug: Saquinavir  Drug: Lamivudine  Drug: Stavudine	Phase III

Further Study Details: 

Expected Total Enrollment:  24

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 above,  Genders Eligible for Study:  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.

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

Study ID Numbers:  229P; NR15690/M61021
Record last reviewed:  December 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002397
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08