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.

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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.