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


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Ethosuximide Capsules

Zarontin



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

This study has been completed.

Sponsored by: Glaxo Wellcome
Information provided by: AIDS Clinical Trials Information Service

Purpose

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

Condition Treatment or Intervention
HIV Infections
Kidney Failure, Chronic
 Drug: Zidovudine

MedlinePlus related topics:  AIDS;   Kidney Failure

Study Type: Interventional
Study Design: Treatment, Dose Comparison

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.


        Location Information


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

        More Information

        Study ID Numbers:  014H; 27433-19
        Record last reviewed:  May 1990
        Last Updated:  October 13, 2004
        Record first received:  November 2, 1999
        ClinicalTrials.gov Identifier:  NCT00002047
        Health Authority: United States: Food and Drug Administration
        ClinicalTrials.gov processed this record on 2005-04-08


        Source: ClinicalTrials.gov
        Cache Date: April 9, 2005

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        Page Updated: June 1, 2005
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