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

Completed · Not applicable

Conditions studied: HIV Infections, Kidney Failure, Chronic

In brief

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

Key facts

Study ID

NCT00002047

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Maryland at Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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