Search / Trial NCT00001001

A Study of Zidovudine in HIV-Infected Patients With Liver Disease

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of February 21, 2024

Completed

Keywords

Liver Liver Diseases Liver Function Tests Hiv Seropositivity Acquired Immunodeficiency Syndrome Zidovudine Biological Availability

Description

AZT is the only antiviral agent that has been shown to be effective in patients with severe HIV infection. However, AZT is largely eliminated from the body through a biochemical reaction that takes place in the liver, and it is possible that patients with underlying liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently, with the result that they are susceptible to an increased risk of serious drug toxicity. This study will examine the pharmacokinetics, elimination, and metabolism of AZT in patients with liver disease. Guidelines developed from the data will ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed after completion of day 2 of study:
  • Prior medications may be resumed.
  • Concurrent Treatment:
  • Allowed after completion of day 2 of study:
  • Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma.
  • The study will be divided into three groups of cooperative patients according to mild, moderate, or severe liver disease. Severity of disease will be assessed within 7 days of entry into the study according to laboratory values. Patients must have normal kidney function. No medications should be taken for 48 hours prior to entering the study. Hemophiliacs are included.
  • Prior Medication:
  • Allowed:
  • Zidovudine (AZT) if discontinued at least 48 hours prior to study entry.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients will be excluded from the study if unacceptable toxicity develops or if an illness requiring concurrent treatment develops.
  • Concurrent Medication:
  • Excluded within 48 hours of study entry:
  • All medications. Medication may be resumed after completion of day 2 of the study.
  • Concurrent Treatment:
  • Excluded within 48 hours of study entry:
  • All treatments. Treatment may be resumed after completion of day 2 of the study.
  • Patients will be excluded for the following reasons:
  • Presence of active opportunistic infections, with the exception of active or chronic hepatitis B virus or hepatitis D virus infection, or ongoing therapy for an opportunistic infection.
  • Thrombocytopenia, with platelets less than 50000 platelets/mm3.
  • Neutropenia, with polymorphonuclear leukocytes less than 1000 cells/mm3.
  • Renal insufficiency, with creatinine greater than 1.5 mg/dl.
  • Acute viral hepatitis within 30 days of the study.
  • Patients who are expected to be noncompliant or who are unwilling to sign an informed consent statement.
  • Prior Medication:
  • Excluded within 48 hours of study entry:
  • All medications. Medication may be resumed after completion of day 2 of the study.
  • Prior Treatment:
  • Excluded within 30 days of study entry:
  • Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma. Treatment may be resumed after completion of day 2 of the study.
  • Active drug or alcohol abuse.

Attachments

readout_NCT00001001_2024-02-21.pdf

4.5 MB

NCT00001001_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Seattle, Washington, United States

Worcester, Massachusetts, United States

Chapel Hill, North Carolina, United States

Boston, Massachusetts, United States

Hershey, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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