Completed

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

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What is being tested

Zidovudine

Drug
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Phase 3
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
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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. 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.

Official TitleA Placebo-Controlled Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS-Associated Kaposi's Sarcoma 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
240 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

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 Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 22 locations
Suspended
Los Angeles County - USC Med CtrLos Angeles, United StatesSee the location
Suspended
UCLA CARE CtrLos Angeles, United States
Suspended
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspended
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United States

Completed22 Study Centers