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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002163 |
Purpose
To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS dementia complex and to assess the safety and tolerance of the treatment regimens.
| Condition | Intervention | Phase |
|---|---|---|
|
AIDS Dementia Complex HIV Infections |
Drug: Abacavir sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex |
Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
NOTE:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
NOTE:
Risk Behavior:
Excluded:
Current alcohol or illicit drug use which may interfere with the patient's ability to comply with the study protocol.
Required:
Required:
Contacts and Locations| United States, California | |
| HIV Neurobehavioral Research Ctr | |
| San Diego, California, United States, 92103 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| United States, Maryland | |
| Johns Hopkins Univ School of Medicine | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Washington Univ Med Ctr | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Columbia Univ / Sergievsky Ctr | |
| New York, New York, United States, 10032 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Univ of North Carolina School of Medicine | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Canada, Manitoba | |
| Univ of Manitoba / Faculty of Medicine | |
| Winnipeg, Manitoba, Canada | |
| Canada, Ontario | |
| Wellesley Hosp | |
| Toronto, Ontario, Canada | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002163 History of Changes |
| Other Study ID Numbers: | 238B, CNAB 3001 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Acquired Immunodeficiency Syndrome AIDS Dementia Complex Antiviral Agents abacavir |
|
HIV Infections Acquired Immunodeficiency Syndrome AIDS Dementia Complex Dementia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Abacavir Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |