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 Details — Status: Completed

Administrative data

• NCT number: NCT00002246
• Other study ID #: 244E
• Secondary ID: AI455-064
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: April 28, 2011
• Start date: October 1997
• Est. completion date: March 1999

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1999
• Est. primary completion date: March 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Are at least 13 years old (need consent if under 18).

• Have AIDS Dementia Complex.

• Have been on a stable anti-HIV drug regimen for at least 8 weeks prior to study entry.

• Agree to use effective methods of birth control during the study.

• Are available for at least 16 weeks of study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have ever taken d4T.

• Have a neurological (brain/spinal cord) disease, such as chronic seizures or head injury, or certain other conditions that would interfere with your ability to complete the study.

• Are pregnant or breast-feeding.

• Abuse alcohol or drugs.

• Have peripheral neuropathy or a newly diagnosed AIDS-defining infection that requires treatment at the time of study enrollment.

• Have received certain medications.

• Cannot take medications by mouth.

• Have severe diarrhea for at least 7 days in a row within 30 days prior to study entry.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS Dementia Complex
• Dementia
• HIV Infections

Intervention

Drug:
• Stavudine

Locations

Country	Name	City	State
Australia	National Centre in HIV Epidemiology and Clinical Research	Sydney
United Kingdom	Charing Cross and Westminster Med School	London SW 10
United States	Mount Sinai Hosp	New York	New York
United States	HIV Neurobehavioral Research Ctr	San Diego	California
United States	AIDS ReSEARCH Alliance	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm