Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002246
First received: November 2, 1999
Last updated: April 28, 2011
Last verified: April 2011

November 2, 1999
April 28, 2011
October 1997
March 1999   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002246 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
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.

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.

Interventional
Phase 3
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
  • AIDS Dementia Complex
  • HIV Infections
Drug: Stavudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 1999
March 1999   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   United Kingdom
 
NCT00002246
244E, AI455-064
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Chair: B Brew
Bristol-Myers Squibb
April 2011

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