NCT00002246

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• AIDS Dementia Complex
• HIV Infections

Interventions

Type	Name	Description
DRUG	Stavudine

Timeline

• Start date: 1997-10-01
• Primary completion: 1999-03-01
• Completion: 1999-03-01
• First posted: 2001-08-31
• Last updated: 2011-05-04

Locations

5 sites across 3 countries: United States, Australia, United Kingdom