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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Kidney Failure, Chronic

Intervention: Zidovudine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Glaxo Wellcome

Summary

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

Clinical Details

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

Study design: Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Locations and Contacts

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


Last updated: June 23, 2005

Page last updated: August 23, 2015

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