A Study of Zidovudine in HIV-Infected Patients With Liver Disease
Status:
Completed
Trial end date:
1990-05-01
Target enrollment:
Participant gender:
Summary
To examine the pharmacokinetics (blood levels) and bioavailability of zidovudine (AZT) given
to patients with HIV infection and chronic liver disease. The specific aim of the study is to
provide data permitting the development of guidelines for use of AZT in patients with mild,
moderate, or severe liver disease.
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 be helpful in managing AZT treatment
of these HIV-infected persons and will indicate whether the dose of AZT administered should
be adjusted to compensate for any changes in its bioavailability and/or pharmacokinetics.
Phase:
N/A
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)