A Study of Azithromycin in HIV-Infected Patients

Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects

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.

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.