Bacterial Infections, HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, Azithromycin, Bacterial Infections
Brief summary
To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.
Detailed description
Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.
Interventions
DRUGAzithromycin
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed