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Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
This study has been completed.
Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002047
  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

MedlinePlus related topics: AIDS Dialysis Kidney Failure
Drug Information available for: Zidovudine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
  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
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

Study ID Numbers: 014H, 27433-19
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002047  
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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Renal Insufficiency
Acquired Immunodeficiency Syndrome
Kidney Failure, Chronic
Zidovudine
AIDS-Related Complex
Immunologic Deficiency Syndromes
Virus Diseases
Urologic Diseases
Renal Insufficiency, Chronic
HIV Infections
Sexually Transmitted Diseases
Kidney Diseases
Retroviridae Infections
Kidney Failure

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009