title: Evaluation of an intensive intermittent-induction regimen and duration of short-course treatment for human immunodeficiency virus-related pulmonary tuberculosis. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) and the AIDS Clinical Trials Group (ACTG).
abstract: This study examined whether adding levofloxacin to a standard four-drug regimen improved the 8-week culture response and compared effectiveness of 9 versus 6 months of intermittent therapy for human immunodeficiency virus-related pansusceptible pulmonary tuberculosis. Patients were randomized to receive either four or five drugs, the fifth being levofloxacin. Patients who completed induction therapy were randomized to complete 9 versus 6 months of intermittent therapy with isoniazid and rifampin. In the randomized induction phase, 97.3% of patients in the four-drug group and 95.8% in the five-drug group had sputum culture conversion at 8 weeks (P = 1.00). In the continuation phase, one patient (2%) assigned to 9 months and two patients (3.9%) assigned to 6 months of therapy had treatment failure/relapse (P = 1.00). In conclusion, this study showed that levofloxacin added no benefit to a highly effective, largely intermittent, four-drug induction regimen. Both 9 and 6 months of intermittent therapy were associated with low treatment failure/relapse rates.
authors.affiliation: Division of Infectious Disease, Harlem Hospital Center, New York, New York 10037, USA.
authors.forename: W M
authors.initials: WM
authors.lastname: el-Sadr
authors.forename: D C
authors.initials: DC
authors.lastname: Perlman
authors.forename: J P
authors.initials: JP
authors.lastname: Matts
authors.forename: E T
authors.initials: ET
authors.lastname: Nelson
authors.forename: D L
authors.initials: DL
authors.lastname: Cohn
authors.forename: N
authors.initials: N
authors.lastname: Salomon
authors.forename: M
authors.initials: M
authors.lastname: Olibrice
authors.forename: F
authors.initials: F
authors.lastname: Medard
authors.forename: K D
authors.initials: KD
authors.lastname: Chirgwin
authors.forename: D
authors.initials: D
authors.lastname: Mildvan
authors.forename: B E
authors.initials: BE
authors.lastname: Jones
authors.forename: E E
authors.initials: EE
authors.lastname: Telzak
authors.forename: O
authors.initials: O
authors.lastname: Klein
authors.forename: L
authors.initials: L
authors.lastname: Heifets
authors.forename: R
authors.initials: R
authors.lastname: Hafner
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004977:Ethambutol / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage / Q000627:therapeutic use; D064704:Levofloxacin; D008297:Male; D008826:Microbial Sensitivity Tests; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000302:isolation & purification; D015242:Ofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D011718:Pyrazinamide / Q000008:administration & dosage / Q000627:therapeutic use; D012008:Recurrence; D012293:Rifampin / Q000008:administration & dosage / Q000627:therapeutic use; D013183:Sputum / Q000382:microbiology; D016896:Treatment Outcome; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
chemical_list: D000995:Antitubercular Agents; D011718:Pyrazinamide; D064704:Levofloxacin; D004977:Ethambutol; D015242:Ofloxacin; D007538:Isoniazid; D012293:Rifampin