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

HIV Infections Clinical Trial

Official title:
A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002246
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 3
Start date October 1997
Completion date March 1999
View Details
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