Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

Launched by GLAXO WELLCOME · Aug 30, 2001

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Eligibility criteria

• • 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.