The Safety and Effectiveness of Zidovudine (AZT) in the Treatment of HIV Infection in Patients With AIDS and Advanced ARC
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: For fever control and mild analgesia, modest doses of aspirin or nonprescription doses of ibuprofen may be used with caution; prolonged (> 72 hours) administration is not advised without dose supervision. Patients must have a documented history of positive HIV antibody by ELISA, or positive result by ELISA at study entry and be in one of the following categories: AIDS patients recovered from one or more episodes of categorically confirmed Pneumocystis carinii pneumonia (PCP) who were previously enrolled in the zidovudine (AZT) treatment IND protocol. Patients who qualify for AZT under the labeling: (a) patients with a prior episode of cytologically confirmed PCP; (b) patients with a prior episode of any other AIDS defining opportunistic infection and < 200 T4 cells; (c) patients with advanced AIDS related complex (ARC) as defined by the clinical diagnosis of mucocutaneous candidiasis and/or unexplained weight loss (= or > 15 lbs or > 10 percent of total body weight within the previous 3 months) and < 200 T4 cells and one or more of the following symptoms: (1) fever > 100 degrees F without infectious cause of > 3 weeks duration; (2) clinical diagnosis of hairy leukoplakia; (3) herpes zoster infection within 3 months of entry; (4) unexplained diarrhea after 3 samples eliminating ova, parasites, cryptosporidia, and Mycobacterium avium-intracellulare. Note: Kaposi's sarcoma without any of the symptoms listed above, regardless of total T4 lymphocyte count, does not constitute an indication for AZT treatment under the labeling. Exclusion Criteria Co-existing Condition: Patients whose symptoms do not fit into the categories described in Disease Status and General Inclusion Criteria are excluded. Concurrent Medication: Excluded: Acetaminophen.
Sites / Locations
- LaJolla Veterans Administration Med Ctr
- Los Angeles County - USC Med 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
- Louisiana State Univ Med Ctr / Tulane Med School
- Tulane Univ School of Medicine
- Johns Hopkins Hosp
- Beth Israel Deaconess - West Campus
- Beth Israel Deaconess Med Ctr
- Univ of Minnesota
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Jack Weiler Hosp / Bronx Municipal Hosp
- SUNY / Erie County Med Ctr at Buffalo
- 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
- Univ of Pittsburgh Med School