A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
NCT ID: NCT00000994
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
1990-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Valentine FT
Role: STUDY_CHAIR
Locations
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Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States
Stanford Univ School of Medicine
Stanford, California, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
SUNY / State Univ of New York
Syracuse, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Countries
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References
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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.
Other Identifiers
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10977
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 001
Identifier Type: -
Identifier Source: org_study_id