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

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002047

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Kidney Failure, Chronic	Drug: Zidovudine	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.