A Study of Azithromycin in HIV-Infected Patients

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002344

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: April 1996

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002344 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Azithromycin in HIV-Infected Patients
Official Title ^ICMJE	Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects
Brief 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Intervention Model: Parallel Assignment Primary Purpose: Treatment
Condition ^ICMJE	Bacterial Infections HIV Infections
Intervention ^ICMJE	Drug: Azithromycin
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00002344
Other Study ID Numbers ^ICMJE	226C, 066-060
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 1996
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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