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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Glaxo Wellcome


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002047

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: May 1990
History of Changes
Purpose

Purpose

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

Condition Intervention
HIV Infections
Kidney Failure, Chronic

Drug : Zidovudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002047

Locations

United States, Maryland
Univ of Maryland at Baltimore
Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

Glaxo Wellcome
More Information

More Information


Responsible Party: Glaxo Wellcome  
ClinicalTrials.gov Identifier: NCT00002047   History of Changes  
Other Study ID Numbers: 014H  
  27433-19  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Kidney Failure, Chronic
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Renal Dialysis

Additional relevant MeSH terms:
HIV Infections
Renal Insufficiency
Kidney Failure, Chronic
Zidovudine

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.