- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002344
A Study of Azithromycin in HIV-Infected Patients
Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85040
- Harris Laboratories Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: PARALLEL
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 226C
- 066-060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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