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

Phase 3

Completed

• Conditions: AIDS Dementia Complex; HIV Infections

• Registration Number: NCT00002246
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Study Timeline

• Study Start: 1997-10
• Primary Completion: 1999-03
• Study Completion: 1999-03
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-13
• Disposition First Submitted QC: 2011-04-13
• Disposition First Posted: 2011-04-25
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

HIV Neurobehavioral Research Ctr; 🇺🇸 San Diego, California, United States

AIDS ReSEARCH Alliance; 🇺🇸 West Hollywood, California, United States

Mount Sinai Hosp; 🇺🇸 New York, New York, United States

National Centre in HIV Epidemiology and Clinical Research; 🇦🇺 Sydney, Australia

Charing Cross and Westminster Med School; 🇬🇧 London SW 10, United Kingdom