A Clinical Study Examining the Pharmacokinetics and Bioavailability of Azidothymidine (AZT, Zidovudine) in Patients With Human Immunodeficiency Virus (HIV) Infection and Hepatic Disease

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety