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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
History of Changes
  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 3

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

Resource links provided by NLM:

MedlinePlus related topics: Dementia HIV/AIDS
Drug Information available for: Stavudine
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 20
Study Start Date: October 1997
Study Completion Date: March 1999
Primary Completion Date: March 1999 (Final data collection date for primary outcome measure)
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

Additional 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

No publications provided

ClinicalTrials.gov Identifier: NCT00002246     History of Changes
Other Study ID Numbers: 244E, AI455-064
Study First Received: November 2, 1999
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
AIDS Dementia Complex
Dementia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Stavudine
Reverse Transcriptase Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2013