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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

HIV Infections
Kidney Failure, Chronic

Treatments

Drug: Zidovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002047
014H
27433-19

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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