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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

October 1, 2007

Start Date ^ICMJE

October 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002246 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Pharmacokinetics Study

Condition ^ICMJE

AIDS Dementia Complex
HIV Infections

Intervention ^ICMJE

Drug: Stavudine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00002246

Responsible Party

Study ID Numbers ^ICMJE

244E, AI455-064

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

B Brew

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP