CompletedPhase 3

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

United States315 participants

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria 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. Exclusion Criteria * 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: * Zidovudine (AZT). * Excluded within 14 days of study entry: * Systemic anti-infectives. * Excluded within 30 days of study entry: * Immunomodulators and biologi…

Trial details

NCT IDNCT00000702

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL