TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
Status:
Completed
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine whether one or two four-month regimens of
tuberculosis treatment are as effective as a standard six-month regimen for treatment of
pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week,
with direct observation of each dose by a health-care worker at least five of the seven days
of each week.
The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and
pyrazinamide followed by four months of isoniazid and rifampin.
The first short regimen is a single substitution of rifapentine for rifampin: two months of
isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and
rifapentine.
The second short regimen is a double substitution of rifapentine for rifampin and
moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and
pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin.
Target enrollment is 2500 participants. Each study participant will remain in the study for
18 months in order to include at least 12 months of evaluation of whether the participant's
TB recurs.
Phase:
Phase 3
Details
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborator:
AIDS Clinical Trials Group
Treatments:
Ethambutol Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination Rifampin Rifapentine