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A Study of Azithromycin in HIV-Infected Patients

This study has been completed.
Study NCT00002344.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Study of Azithromycin in HIV-Infected Patients
Official Title  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 Phase Phase I
Study Type  Interventional
Study Design  Treatment, Parallel Assignment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bacterial Infections
HIV Infections
Intervention  Drug: Azithromycin
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  12
Start Date 
Completion Date
Eligibility 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.

Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002344
Organization ID 226C
Secondary IDs †† 066-060
Study Sponsor  Pfizer
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date April 1996
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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