Ortho's levofloxacin
Executive Summary
Included in treatment regimen of a National Institute of Allergy & Infectious Diseases nationwide clinical trial for persons co- infected with HIV and tuberculosis. The fluoroquinolone is being developed by Ortho in the U.S. under license from Daichii in Japan. The 650-person open-label trial (CPCRA 019/ACTG 222) will evaluate in an induction phase the addition of levofloxacin to the standard treatment regimen of isoniazid (INH supplied by Danbury Pharmacal), vitamin B6, administered with INH (Tishcon Corp.), rifampin (Marion Merrell Dow), ethambutol and pyrazinamide (Lederle) in people with drug-resistant TB, as well as in variations on the drug treatment regimen during the trial's continuation phase. NIAID hopes a shorter treatment regimen or an effective intermittent regimen would increase therapy compliance.