A Study of Azithromycin in HIV-Infected Patients

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Pfizer
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002344

Purpose

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.

Condition	Intervention	Phase
Bacterial Infections HIV Infections	Drug: Azithromycin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment
Official Title:	Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS Bacterial Infections

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002344

Locations

United States, Arizona
Harris Laboratories Inc
Phoenix, Arizona, United States, 85040

Sponsors and Collaborators

Pfizer

More Information

No publications provided

Study ID Numbers:	226C, 066-060
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002344 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Azithromycin
Bacterial Infections

Study placed in the following topic categories:

Virus Diseases
Bacterial Infections
Anti-Bacterial Agents
Sexually Transmitted Diseases, Viral
HIV Infections

Azithromycin
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
HIV Infections
Therapeutic Uses
Azithromycin
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009