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
2 other identifiers
interventional
315
1 country
21
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
August 1, 1990
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Aspirin, in modest doses.
- Ibuprofen, in modest doses.
- Maintenance antibiotic therapy posttherapy for an AIDS-defining opportunistic infection.
- Concurrent Treatment:
- Allowed:
- Blood transfusion if cardiovascular status is compromised.
You may not qualify if:
- Active substance abuse.
- Co-existing Condition:
- Patients with the following conditions will be excluded:
- Concurrent or previous central nervous system infections or neoplasms.
- Active AIDS-defining opportunistic infection.
- Severe premorbid psychiatric illness.
- Confounding neurological disease.
- Concurrent neoplasms.
- Concurrent Medication:
- Excluded:
- Maintenance methadone or naltrexone.
- Acetaminophen.
- Mood- or central nervous system-altering drugs.
- Zidovudine for Pneumocystis carinii pneumonia (PCP).
- Acyclovir.
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Stanford Univ School of Medicine
Stanford, California, 94305, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, 10465, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Washington
Seattle, Washington, 98105, United States
Related Publications (2)
Sidtis JJ, Gatsonis C, Price RW, Singer EJ, Collier AC, Richman DD, Hirsch MS, Schaerf FW, Fischl MA, Kieburtz K, et al. Zidovudine treatment of the AIDS dementia complex: results of a placebo-controlled trial. AIDS Clinical Trials Group. Ann Neurol. 1993 Apr;33(4):343-9. doi: 10.1002/ana.410330403.
PMID: 8489204BACKGROUNDPrice RW, Koch MA, Sidtis JJ, Feinberg J, Collier A, Kennedy C, Singer E, Price S. Zidovudine (AZT) treatment of the AIDS dementia complex (ADC): results of a placebo-controlled, multicentered therapeutic trial. Int Conf AIDS. 1989 Jun 4-9;5:407 (abstract no WBP331)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
R Price
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
August 1, 1990
Last Updated
November 3, 2021
Record last verified: 2021-10