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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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HIV Infections Kidney Failure, Chronic

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Zidovudine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Univ of Maryland at Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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27433-19

Identifier Type: -

Identifier Source: secondary_id

014H