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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: HIV Infections; Kidney Failure, Chronic

Treatments: Drug: Zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002047

014H

27433-19

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.