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

Primary Purpose

HIV Infections, Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Kidney Failure, Chronic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Renal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Maryland at Baltimore

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002047
Brief Title
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
Official Title
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Kidney Failure, Chronic
Keywords
Kidney Failure, Chronic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Renal Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ of Maryland at Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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