A Study of Azithromycin in HIV-Infected Patients

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Bacterial Infections HIV Infections

Interventions

AzithromycinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Harris Laboratories Inc

Phoenix, Arizona, United States

Data from ClinicalTrials.gov

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