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

April 28, 2011 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sydney, Australia
        • National Centre in HIV Epidemiology and Clinical Research
      • London SW 10, United Kingdom
        • Charing Cross and Westminster Med School
    • California
      • San Diego, California, United States, 92103
        • HIV Neurobehavioral Research Ctr
      • West Hollywood, California, United States, 90069
        • AIDS Research Alliance
    • New York
      • New York, New York, United States, 100296574
        • Mount Sinai Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: B Brew

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Primary Completion (Actual)

March 1, 1999

Study Completion (Actual)

March 1, 1999

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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