A Study of Azithromycin in HIV-Infected Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Azithromycin

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.