Expired Study
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Phoenix, Arizona 85040


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.


Study summary:

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.


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.


NCT ID:

NCT00002344


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Phoenix, Arizona 85040
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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