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A Study of Azithromycin in HIV-Infected Patients | Clinical Trials | Clareo Health

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A Study of Azithromycin in HIV-Infected Patients

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

NCT00002344•Pfizer

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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:
+2 more criteria

Locations (1)

Harris Laboratories Inc

Phoenix, Arizona, United States

Key Dates

Last Updated

June 24, 2005

Enrollment

Estimated participants

Conditions

Bacterial InfectionsHIV Infections

Interventions

Azithromycin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Azithromycin in HIV-Infected Patients

Inclusion Criteria

Exclusion Criteria

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