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

Completed · Phase 3

Conditions studied: AIDS Dementia Complex, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000702

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

315

Expected to finish

1990-08-01

Last updated by the study team

2021-11-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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:

Where it is running

• 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

Full record on ClinicalTrials.gov

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