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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • San Diego, California, United States, 921036325
        • Univ of California / San Diego Treatment Ctr
      • Stanford, California, United States, 94305
        • Stanford Univ School of Medicine
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
    • Louisiana
      • 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
        • Charity Hosp / Tulane Univ Med School
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard (Massachusetts Gen Hosp)
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
    • New York
      • Bronx, New York, United States, 10461
        • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
      • Bronx, New York, United States, 10465
        • Jack Weiler Hosp / Bronx Municipal Hosp
      • Buffalo, New York, United States, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • Elmhurst, New York, United States, 11373
        • City Hosp Ctr at Elmhurst / Mount Sinai Hosp
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr / Peter Krueger Clinic
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Julio Arroyo
    • Washington
      • Seattle, Washington, United States, 98105
        • Univ of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: R Price

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

August 1, 1990

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 005
  • 10981 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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