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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002047
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1990

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002047 on ClinicalTrials.gov Archive Site
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Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

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

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Interventional
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Primary Purpose: Treatment
  • HIV Infections
  • Kidney Failure, Chronic
Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002047
014H, 27433-19
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
May 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP