Expired Study
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Baltimore, Maryland 21201


Purpose:

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


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.


NCT ID:

NCT00002047


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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