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

This study has been completed.
Study NCT00002246.   Last updated on October 1, 2007.   Information provided by Bristol-Myers Squibb

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Descriptive Information Fields
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
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  Interventional
Study Design  Treatment, Pharmacokinetics Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  AIDS Dementia Complex
HIV Infections
Intervention  Drug: Stavudine
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  20
Start Date  October 1997
Completion Date
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.
Gender Both
Ages 13 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Australia,   United Kingdom
Administrative Information Fields
NCT ID  NCT00002246
Organization ID 244E
Secondary IDs †† AI455-064
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Study Chair:     B Brew        
Information Provided By Bristol-Myers Squibb
Verification Date October 2007
First Received Date  November 2, 1999
Last Updated Date October 1, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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