A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
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
2 other identifiers
interventional
240
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
May 1, 1990
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
Stanford Univ School of Medicine
Stanford, California, 94305, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY / State Univ of New York
Syracuse, New York, 13210, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Related Publications (1)
Chaisson RE, Fuchs E, Stanton DL, Quinn TC, Hendricksen C, Bartlett JG, Farzadegan H. Racial heterogeneity of HIV antigenemia in people with HIV infection. AIDS. 1991 Feb;5(2):177-80. doi: 10.1097/00002030-199102000-00007.
PMID: 1903261BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Valentine FT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 1990
Last Updated
November 4, 2021
Record last verified: 2021-10