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

This study has been completed.

Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00002246
  Purpose

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.


Condition Intervention Phase
AIDS Dementia Complex
HIV Infections
Drug: Stavudine
Phase III

MedlinePlus related topics:   AIDS    Dementia   

ChemIDplus related topics:   Zidovudine    Stavudine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Pharmacokinetics Study
Official Title:   A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:   20
Study Start Date:   October 1997

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002246

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

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Study Chair:     B Brew    
  More Information


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
 

Study ID Numbers:   244E, AI455-064
First Received:   November 2, 1999
Last Updated:   October 1, 2007
ClinicalTrials.gov Identifier:   NCT00002246
Health Authority:   United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
AIDS Dementia Complex  
Zidovudine  
Stavudine  
Reverse Transcriptase Inhibitors  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Stavudine
AIDS Dementia Complex
Acquired Immunodeficiency Syndrome
Zidovudine
Central Nervous System Diseases
Brain Diseases
Immunologic Deficiency Syndromes
Cognition Disorders
Virus Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
HIV Infections
Sexually Transmitted Diseases
Dementia
Retroviridae Infections
Delirium

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 16, 2008




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