A Study of Azithromycin in HIV-Infected Patients

Condition(s) targeted: Bacterial Infections; HIV Infections

Intervention: Azithromycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

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.

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

Study design: Treatment, Parallel Assignment

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): 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.

Harris Laboratories Inc, Phoenix, Arizona 85040, United States

Last updated: June 23, 2005