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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000994

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

240

Expected to finish

1990-05-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.
• 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:

Where it is running

• 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

Full record on ClinicalTrials.gov

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