Tuberculosis Clinical Trial
Official title:
Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection
Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.
Approximately one-third of the world's population is infected with Mycoplasma tuberculosis;
7 to 8 million new cases of active TB occur each year. TB is the second most common
infectious cause of death worldwide. Appropriate treatment of persons with active TB is very
important in limiting the transmission of M. tuberculosis and preventing TB-related
mortality. Current therapy requires 6 months of a four-drug regimen of isoniazid (INH),
rifampin (RIF), pyrazinamide (PZA), and EMB.
The development of alternative regimens is a priority, and new classes of antituberculosis
agents are needed to provide treatment options for patients with drug-resistant disease.
This study will evaluate the effectiveness of replacing EMB with MOX in a multi-drug regimen
in the initial phase of treatment of smear-positive pulmonary TB in patients with and
without HIV infection.
Participants in this study will be randomly assigned to receive either a MOX-containing drug
regimen or the standard EMB-containing drug regimen for 8 weeks. Participants will have
study visits weekly during these 8 weeks. After 8 weeks, participants will discontinue MOX,
EMB, and PZA and will continue taking INH and RFP for 4 months. Participants will have study
visits at Months 4, 6, 12, and 18. Study visits will include a medical interview, physical
exam, blood and urine tests, and sputum tests for TB.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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