Expired Study
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New York, New York 10029


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.


Study summary:

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.


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.


NCT ID:

NCT00002397


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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