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
NCT ID: NCT00000702
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
315 participants
INTERVENTIONAL
1990-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zidovudine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
* Rifampin or derivatives.
* Drugs with antiretroviral activity.
* Experimental agents.
The following patients will be excluded from the study:
* Patients requiring ongoing therapy for an AIDS-defining opportunistic infection.
* Patients with a history of Mycobacterium avium intracellulare infection.
* Patients with a history of Pneumocystis carinii pneumonia infection.
* Patients with a daily temperature of 38 degrees C or more for 1 month.
Prior Medication:
Excluded:
* Zidovudine (AZT).
* Excluded within 14 days of study entry:
* Systemic anti-infectives.
* Excluded within 30 days of study entry:
* Immunomodulators and biologic response modifiers.
* Any investigational agent.
* Cytotoxic chemotherapy for Kaposi's sarcoma.
Prior Treatment:
Excluded:
* Radiation therapy.
Patients must demonstrate the following clinical and laboratory findings:
* No currently active AIDS-defining opportunistic infections.
* One negative blood culture for Mycobacterium avium intracellulare within 4-6 weeks prior to study entry.
* Constitutionally well without persistent fever.
* Less than 25 Kaposi's sarcoma lesions and less than 10 new lesions during the 30 days prior to study entry. Patients may have stable or indolently progressive mucocutaneous Kaposi's sarcoma.
* Characteristic clinical symptoms and signs of AIDS dementia complex.
* Abnormalities on 2 or more of 7 neuropsychological motor tests in the Neurological Screening Battery.
* Estimated premorbid IQ equal to or greater than 70 (+ or - 5), which is consistent with completion of sixth grade.
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
R Price
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA CARE Ctr
Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
Stanford Univ School of Medicine
Stanford, California, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Price 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)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10981
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 005
Identifier Type: -
Identifier Source: org_study_id