NCT00002344CompletedPhase 1
Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
Study Overview
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 Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have:
- •HIV seropositivity.
- •CD4 count <= 500 cells/mm
- •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:
- •Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.
- •Known drug or alcohol dependence.
Investigators
Study Sites (1)
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