HIV Infections, Kidney Failure, Chronic
Conditions
Keywords
Kidney Failure, Chronic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Renal Dialysis
Brief summary
To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.
Interventions
DRUGZidovudine
Sponsors
Glaxo Wellcome
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must have: * A positive HIV antibody test (ELISA confirmed by Western blot). * Chronic renal failure managed by a stable hemodialysis regimen. * Acceptable hepatic function defined by specified lab values. * Life expectancy \> 6 months. * Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry.
Exclusion criteria
Co-existing Condition: Patients with the following are excluded: * Active, serious opportunistic infections at the time of study entry. * Fever \> 100 degrees F at study entry. * Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss). Patients with the following are excluded: * Active, serious opportunistic infections at the time of study entry. * Fever \> 100 degrees F at study entry. * Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss). Prior Medication: Excluded within 2 weeks of study entry: \- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity. Excluded within 4 weeks of study entry: \- Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2. Excluded within 8 weeks of study entry: \- Other antiretroviral agents (e.g., zidovudine \[AZT\], suramin, ribavirin, HPA-23, foscarnet, dextran sulfate, disulfiram, ddA/ddC, or dideoxycytidine). Active drug or alcohol abuse.
Countries
United States
Outcome results
None listed