HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine
Brief summary
To obtain information about the long-term safety and toxicity of zidovudine (AZT). To ascertain whether interruption/resumption at a lower dosage is the optimal management of AZT toxicity. Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT.
Detailed description
Because of the high incidence of toxicity and the relatively short-term follow-up of the patients due to the early ending of the Phase II placebo-controlled experiment, it is valuable to continue to get information on the long-term toxicity of AZT. This study provides AZT for 6 months to AIDS patients who were previously enrolled in the AZT Treatment IND protocol and to patients who qualify for AZT under the drug labeling. Patients are randomized to 1 of 2 regimens for management of toxicity.
Interventions
DRUGZidovudine
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed