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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00002246 |
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 |
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AIDS Dementia Complex HIV Infections |
Drug: Stavudine |
Phase III |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | October 1997 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
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 |
Study Chair: | B Brew |
Study ID Numbers: | 244E, AI455-064 |
Study First Received: | November 2, 1999 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00002246 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AIDS Dementia Complex Zidovudine Stavudine Reverse Transcriptase Inhibitors |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine AIDS Dementia Complex Acquired Immunodeficiency Syndrome Zidovudine Central Nervous System Diseases Brain Diseases Antiviral Agents Immunologic Deficiency Syndromes |
Cognition Disorders Reverse Transcriptase Inhibitors Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Anti-Retroviral Agents Mental Disorders HIV Infections Sexually Transmitted Diseases Dementia Retroviridae Infections Delirium |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral AIDS Dementia Complex Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Infection Brain Diseases Reverse Transcriptase Inhibitors Anti-Retroviral Agents Mental Disorders Therapeutic Uses Dementia Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Delirium, Dementia, Amnestic, Cognitive Disorders HIV Infections Sexually Transmitted Diseases |