Status:
COMPLETED
A Study of Zidovudine in HIV-Infected Patients With Liver Disease
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Liver Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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 pl...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1990
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00001001
End Date
May 1 1990
Last Update
November 4 2021
Active Locations (5)
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1
Boston Med Ctr
Boston, Massachusetts, United States, 02118
2
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, United States, 01655
3
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
4
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850