A Study of AZT in HIV-Infected Patients With AIDS-Related Kaposi's Sarcoma
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Zidovudine
Eligibility 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.
Sites / Locations
- Los Angeles County - USC Med Ctr
- UCLA CARE Ctr
- Univ of California / San Diego Treatment Ctr
- San Francisco AIDS Clinic / San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Stanford Univ School of Medicine
- Charity Hosp / Tulane Univ Med School
- Louisiana State Univ Med Ctr / Tulane Med School
- Tulane Univ School of Medicine
- Johns Hopkins Hosp
- Harvard (Massachusetts Gen Hosp)
- Univ of Minnesota
- Bronx Veterans Administration / Mount Sinai Hosp
- SUNY / Erie County Med Ctr at Buffalo
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
- Beth Israel Med Ctr / Peter Krueger Clinic
- Bellevue Hosp / New York Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Mount Sinai Med Ctr
- Univ of Rochester Medical Center
- SUNY / State Univ of New York
- Duke Univ Med Ctr