Bacterial Infections, HIV Infections
Conditions
Keywords
Azithromycin, Bacterial Infections
Brief summary
To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients. The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.
Detailed description
The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population. Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods.
Interventions
DRUGAzithromycin
Sponsors
Pfizer
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients must have: * HIV seropositivity. * CD4 count \<= 500 cells/mm3. * NO active AIDS opportunistic infection.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Other active intercurrent illness. * Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies. * Signs or symptoms of severe illness that would preclude study participation. * Known allergies to macrolide antibiotics. Patients with the following prior condition are excluded: Clinically important change in baseline status 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