Rifapentine Plus Moxifloxacin for Treatment of Pulmonary Tuberculosis
Status:
Terminated
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Helio Fraga Reference Center, Fiocruz Municipal Health Secretary of Rio de Janeiro Universidade Federal do Rio de Janeiro