A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma

October 28, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma

To determine whether taking zidovudine (AZT) will change the natural course of HIV infection in patients with AIDS-associated Kaposi's sarcoma (KS) and whether administering AZT at a similar dose but at different intervals will reduce toxicity in a more manageable treatment plan.

Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients infected with AIDS can benefit from therapy with an effective anti-AIDS virus agent. AZT is a drug that is effective in inhibiting the effects of HIV infection. The study will show whether toxicity of AZT can be reduced in a more manageable treatment plan, and whether AZT therapy will delay the development of opportunistic infections and/or KS lesions.

Patients are divided into two treatment groups, the first receiving AZT for 5 doses a day, and the second receiving AZT for 3 doses per day. A placebo group is divided into two to match the two treatment groups. Study patients are stratified according to whether they have (a) 10 or fewer cutaneous lesions without oral lesions or (b) more extensive cutaneous lesions or oral lesions. Patients are seen on an outpatient basis weekly for the first 2 months, every other week for the next 2 months, and monthly thereafter.

Study Type

Interventional

Enrollment

240

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
      • Los Angeles, California, United States, 90033
        • Los Angeles County - USC Med Ctr
      • San Diego, California, United States, 921036325
        • Univ of California / San Diego Treatment Ctr
      • San Francisco, California, United States, 941102859
        • San Francisco AIDS Clinic / San Francisco Gen Hosp
      • San Francisco, California, United States, 94115
        • Stanford at Kaiser / Kaiser Permanente Med Ctr
      • Stanford, California, United States, 94305
        • Stanford Univ 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)
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
    • New York
      • Bronx, New York, United States, 10468
        • Bronx Veterans Administration / Mount Sinai 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
      • Syracuse, New York, United States, 13210
        • SUNY / State Univ of New York
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Acute treatment for mucocutaneous candidiasis, localized cutaneous herpes simplex, or localized or disseminated zoster infections.

Concurrent Treatment:

Allowed:

  • Blood transfusion for treatment of Grade 3 hemoglobin toxicity if the patient's cardiovascular status is compromised or if the hemoglobin fails to show signs of recovery following withdrawal from the study drug. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).

Patients must have:

  • HIV-related, biopsy-proven Kaposi's sarcoma mucocutaneous lesions without constitutional symptoms.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions will be excluded:

  • Symptomatic, visceral Kaposi's sarcoma.
  • Lymphedema.
  • HIV neurologic disease as determined by a standard neurologic examination and neuropsychological questionnaire.

Concurrent Medication:

Excluded:

  • Aspirin or acetaminophen on a regular basis or for longer than 72 hours without approval of investigator.
  • Cimetidine.
  • Flurazepam.
  • Indomethacin.
  • Ranitidine.
  • Probenecid.
  • Drugs causing anemia, neutropenia, or significant risk of nephrotoxicity.
  • Prophylaxis or chronic suppression of herpes simplex.
  • Treatment of herpes simplex virus cutaneous disease more often than once a month for 5 - 7 days.

Concurrent Treatment:

Excluded:

  • Radiation therapy for treatment of Kaposi's sarcoma lesions.

The following patients will be excluded from the study:

  • Patients with a history of any AIDS-defining opportunistic infection.
  • Patients with any of the following constitutional symptoms with no etiology established:
  • Temperature more than 38 degrees and/or drenching night sweats for more than 1 month; watery diarrhea for 2 or more weeks; weight loss of more than 10 percent.
  • Patients with a history of other systemic malignancies or lymphomas.

Prior Medication:

Excluded:

  • Systemic antineoplastic chemotherapy.
  • Zidovudine (AZT).
  • Excluded within 30 days of study entry:
  • Antiretroviral agents.
  • Immunomodulating agents.
  • Prophylaxis for Pneumocystis carinii pneumonia.
  • Prophylaxis for herpes simplex virus infections.
  • Any other experimental therapy.

Prior Treatment:

Excluded within 30 days of study entry:

  • Any experimental therapy.
  • Active substance abuse.

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)

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)

May 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 4, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 001
  • 10977 (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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