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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002047
• Other study ID #: 014H
• Secondary ID: 27433-19
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Zidovudine

Locations

Country	Name	City	State
United States	Univ of Maryland at Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,