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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
  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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Kidney Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Urologic Diseases
Virus Diseases
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014