Overview

A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

Summary

This study is designed to evaluate the efficacy and safety of clarithromycin given orally at 1 of 3 doses to treat disseminated Mycobacterium avium complex infections (MAC) in patients with AIDS. Mycobacterium avium complex (MAC) is thought to be the most common disseminated bacterial opportunistic infection in AIDS, with clinical prevalence estimates ranging from 15 to 50 percent of all AIDS patients. Clarithromycin, a new macrolide antimicrobial agent, has demonstrated activity against MAC both in the laboratory and in animals. Clinical experience treating AIDS patients with clarithromycin for disseminated MAC is limited. However, early studies have indicated few adverse effects and some improvement in clinical symptoms scores and Karnofsky performance scores over placebo treated patients.

Phase:

Phase 2

Details

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator:

Abbott

Treatments:

Clarithromycin