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A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex

2014-08-27 03:59:13 | BioPortfolio

Summary

The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems involving the brain or spinal cord) in HIV-positive patients.

Description

In this open-label, multicenter, multinational study, ZDV is replaced with d4T in ZDV-containing regimens, or d4T is added to non-ZDV-containing regimens in 20 patients experiencing ADC. Patients are defined as having failed treatment if they progress by one ADC stage on the MSK (Memorial Sloan Kettering) rating scale on study (i.e., from Stage 1 to 2 or Stage 2 to 3). Patients are evaluated on a weekly basis until the dementia deterioration is confirmed to be caused by HIV-1. The effect of d4T-containing regimens is assessed for the following parameters: neurological status, survival, AIDS-defining conditions, CSF (cerebrospinal fluid) and plasma viral load, CSF and blood immunological markers, blood CD4 cell counts, and viral resistance. This study also assesses the pharmacokinetics of d4T in the CSF and in the blood.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Conditions

AIDS Dementia Complex

Intervention

Stavudine

Location

HIV Neurobehavioral Research Ctr
San Diego
California
United States
92103

Status

Completed

Source

Bristol-Myers Squibb

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:13-0400

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Medical and Biotech [MESH] Definitions

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A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.

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