Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection

Date de début de l'étude : 1 octobre 2004

Inclusion Criteria: * Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry. Patients with both pulmonary and extrapulmonary disease are eligible. * Documentation of HIV infection status. If HIV status is unknown at study entry, the participant must consent to testing and results must be available prior to study participation. * Agree to use acceptable methods of contraception Exclusion Criteria: * History of adverse drug reaction to MOX, INH, RIF, PZA, or EMB * Disease or condition for which MOX, INH, RIF, PZA, or EMB is contraindicated * History of more than 14 days of continuous antituberculosis therapy during the previous 2 years or more than 2 months of antituberculosis therapy ever * Active AIDS-related opportunistic infection or malignancy * Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 2 months after study entry * Silicotuberculosis * Central nervous system TB * Pregnant or breastfeeding * Unable to take oral medication * Electrocardiogram (EKG) QTc interval greater than 450 msec * Taking classes IA or III antiarrhythmic agents (quinidine, procainamide, amiodarone, sotalol), cisapride, erythromycin, perphenazine/amitriptyline, phenothiazines, or tricyclic antidepressant * Diseases or conditions for which treatment with other drugs with antituberculosis activity (e.g., rifabutin for MAC prophylaxis) is anticipated during the course of the study