To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in
HIV-infected patients in renal failure receiving maintenance hemodialysis.
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.
