A Study of Azithromycin in HIV-Infected Patients

Launched by PFIZER · Aug 30, 2001

Keywords

ClinConnect 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.

Gender

ALL

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.