A Study of Azithromycin in HIV-Infected Patients

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00002344
• Collaborator: (none)
• Enrollment: 12
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections; HIV Infections	Drug: Azithromycin	Phase 1

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 Assignment
• Primary Purpose: Treatment
• Official Title: Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harris Laboratories Inc	Phoenix	Arizona	United States	85040

Sponsors and Collaborators

• Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00002344
• Other Study ID Numbers: 226C; 066-060
• First Posted: Aug 31, 2001
• Last Update Posted: Jun 24, 2005
• Last Verified: Apr 1, 1996

• Keywords provided by , ,: Azithromycin; Bacterial Infections
• Additional relevant MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Azithromycin

Study Results

No Results Posted as of Jun 24, 2005