Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis
Although effective therapy for tuberculosis is available, TB continues to cause significant problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such as increased severity of illness and death, prolonged infectiousness and transmission in the community, and the development of drug resistance. The development of new treatment strategies with more stronger drugs could lead to shorter and simpler regimens. A TB treatment regimen that allowed treatment duration to be meaningfully decreased would have important public health implications.
This trial will compare the effect and safety of a new oral regimen to that of the standard regimen for the first phase of treatment for pulmonary tuberculosis.
The experimental regimen will consist of the following:
- Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
The standard control intensive phase regimen will consist of the following:
- Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Following intensive phase therapy (the study phase), all patients will be treated with a non-experimental continuation phase regimen.
In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly faster than the standard regimen and this study will be the first step to see if the potential is also there in humans.
|Tuberculosis||Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Randomized, Open-label Trial of a Rifapentine Plus Moxifloxacin-Based Regimen for Intensive Phase Treatment of Smear-Positive Pulmonary Tuberculosis|
- To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy. [ Time Frame: Week 8 ]LJ culture conversion
- To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens. [ Time Frame: Weekly or more frequent ]Study was prematurely terminated and data was not collected for this outcome measure.
|Study Start Date:||November 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid
Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
Other Name: Priftin, Avelox
Active Comparator: 2
Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol
Administered per standard of care for TB treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728507
|Centro de Referência Professor Hélio Fraga - ENSP - FIOCRUZ|
|Curicica, Rio de Janeiro, Brazil, 22.780-192|
|Posto de Saude Albert Sabin|
|Rio de Janeiro, RJ, Brazil, 20211-110|
|Hospital Universitario Clementio Fraga Filho|
|Rio de Janeiro, Brazil|
|Principal Investigator:||Susan Dorman, MD||Johns Hopkins University|