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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000702 |
To test whether zidovudine (AZT) is useful as a treatment for the neurologic syndrome called AIDS dementia complex. To determine how long AZT takes to reach cerebral spinal fluid (CSF), how long, and at what concentration it is found there.
HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex.
Condition | Intervention | Phase |
---|---|---|
AIDS Dementia Complex HIV Infections |
Drug: Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind |
Official Title: | A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection |
Estimated Enrollment: | 315 |
HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex.
The study is done in 2 stages. In Stage 1, patients are randomized to receive placebo or 1 of 2 doses of AZT. Stage 1 lasts for 4 months. In Stage 2, patients who were initially treated with placebo are randomized again and all patients receive AZT. Stage 2 lasts an additional 12 months, during which time there are periodic medical and neurologic evaluations. Before beginning treatment, all patients have a lumbar puncture and a computerized tomographic (CT) scan of the brain. The lumbar puncture is repeated twice during and once at the end of Stage 1; the CT scan is also repeated at the end of Stage 1. Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week for the first 4 weeks and every other week thereafter for the first 4 months of receiving the drug. After 4 months, patients are seen by their physicians at 4 to 12 week intervals.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
Concurrent Medication:
Excluded:
The following patients will be excluded from the study:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Patients must demonstrate the following clinical and laboratory findings:
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Stanford Univ School of Medicine | |
Stanford, California, United States, 94305 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Louisiana State Univ Med Ctr / Tulane Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
Bronx, New York, United States, 10461 | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Beth Israel Med Ctr / Peter Krueger Clinic | |
New York, New York, United States, 10003 | |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
Elmhurst, New York, United States, 11373 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98105 |
Study Chair: | R Price |
Study ID Numbers: | ACTG 005 |
Study First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000702 |
Health Authority: | United States: Federal Government |
AIDS Dementia Complex Zidovudine |
Sexually Transmitted Diseases, Viral 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 |
Antimetabolites Anti-Infective Agents Communicable Diseases 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 |