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

Primary Purpose

AIDS Dementia Complex, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Stavudine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS Dementia Complex focused on measuring AIDS Dementia Complex, Zidovudine, Stavudine, Reverse Transcriptase Inhibitors

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HIV Neurobehavioral Research Ctr
  • AIDS ReSEARCH Alliance
  • Mount Sinai Hosp
  • National Centre in HIV Epidemiology and Clinical Research
  • Charing Cross and Westminster Med School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 28, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00002246
Brief Title
A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
Official Title
A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
March 1999 (Actual)
Study Completion Date
March 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS Dementia Complex, HIV Infections
Keywords
AIDS Dementia Complex, Zidovudine, Stavudine, Reverse Transcriptase Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B Brew
Official's Role
Study Chair
Facility Information:
Facility Name
HIV Neurobehavioral Research Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
AIDS ReSEARCH Alliance
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Mount Sinai Hosp
City
New York
State/Province
New York
ZIP/Postal Code
100296574
Country
United States
Facility Name
National Centre in HIV Epidemiology and Clinical Research
City
Sydney
Country
Australia
Facility Name
Charing Cross and Westminster Med School
City
London SW 10
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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