Evaluation of Zidovudine Pharmacokinetics in Patients With Human Immunodeficiency Virus and Varying Degrees of Renal Insufficiency

Inclusion Criteria Concurrent Medication: Allowed: Symptomatic therapy such as analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy. Aerosolized pentamidine. Discouraged: - Sucralfate or antacids. However if these medications are essential for the patient's management, they should not be given within 8 hours before or 2 hours after the scheduled pharmacokinetic study. - Concurrent Treatment: Allowed: Blood transfusions. Patients must have HIV infection with renal insufficiency and acceptable hepatic and hematologic function. They must have been on dialysis treatment for at least 3 months. Prior Medication: Allowed: Cytotoxic chemotherapy for local mucocutaneous lesions. Aerosolized pentamidine. Exclusion Criteria Concurrent Medication: Excluded: Ongoing therapy for opportunistic infections, including systemic maintenance therapy which cannot be discontinued for the duration of the study, such as amphotericin B or ganciclovir. H-2 blockers. Zidovudine (AZT). Other antiretroviral agents or other experimental therapy. Discouraged: - Sucralfate or antacids. However, if these medications are essential for the patient's management, they should not be given within 8 hours before or 2 hours after the scheduled pharmacokinetic study. - Patients will be excluded from the study for the following reasons: Presence of active opportunistic infections. Severe malabsorption syndrome (persistent diarrhea greater than 4 weeks duration with = or > 4 loose stools per day accompanied by = or > 10 percent unintentional weight loss. Acute illness, febrile or unstable, 48 hours prior to the first pharmacokinetic study. Known sensitivity to zidovudine or thymidine-type agents. Diabetes mellitus requiring treatment. Prior Medication: Excluded: - Treatment for diabetes mellitus. Excluded within 72 hours of study entry: H-2 blockers. Zidovudine (AZT). Excluded within 2 weeks of study entry: Other antiretroviral agents or other experimental therapy. Rifampin or rifampin derivatives. Probenecid. Dilantin. Methadone. Oral contraceptives. Barbiturates. Significant hepatotoxic agents or valproic acid. TMP / SMX. Dapsone. Fansidar. Excluded within 30 days of study entry: - Cytotoxic chemotherapy. Prior Treatment: Excluded within 30 days of study entry: Radiation therapy for local mucocutaneous lesions. Risk Behavior: Active drug or alcohol use which might interfere with the study objectives. Note: Alcohol consumption is prohibited 48 hours prior to the first pharmacokinetic study and during the study. Tobacco smoking is not excluded although tobacco use will be quantified. Patients may not have any of the following diseases or symptoms: Presence of active opportunistic infections. Severe malabsorption syndrome (persistent diarrhea greater than 4 weeks duration with = or > 4 loose stools per day accompanied by = or > 10 percent unintentional weight loss. Acute illness, febrile or unstable, 48 hours prior to the first pharmacokinetic study. Diabetes mellitus.