Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral agents, provided regimen has been stable for at least 1 month. Patients must have: HIV infection. CD4 count <= 200 cells/mm3. No active opportunistic infection (pending discussion with Pfizer Clinician). Prior Medication: Allowed: Prior antiretroviral agents. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active intercurrent illness (pending discussion with the Pfizer Clinician). Allergies to macrolide antibiotics. Signs and symptoms of severe illness that would preclude treatment. Patients with the following prior conditions are excluded: History of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Clinically important change in baseline status within 4 weeks prior to study entry. Condition affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies) within 4 weeks prior to study entry. Prior Medication: Excluded: Investigational drugs including treatment IND drugs within 4 weeks prior to study entry. Known drug or alcohol dependence.