Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Antiretroviral agents, provided regimen has been stable for at least 1 month.
Patients must have:
CD4 count <= 200 cells/mm3.
No active opportunistic infection (pending discussion with Pfizer Clinician).
Prior antiretroviral agents.
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.
Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.