TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens

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.

Conditions

• Tuberculosis

Interventions

DRUG

rifapentine

Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment

DRUG

rifapentine and moxifloxacin

Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol.

DRUG

control

standard six-month treatment

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  collaborator NETWORK

• Centers for Disease Control and Prevention

  lead FED

Principal Investigators

• Susan Dorman, MD · Medical University of South Carolina

• Payam Nahid, MD, MPH · University of California at San Francisco

• Susan Swindells, MBBS · University of Nebraska

• Richard Chaisson, MD · Johns Hopkins University

• Ekaterina V Kurbatova, MD, PhD, MPH · Centers for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-25

Primary Completion

2020-07-31

Completion

2021-05-31

FDA Drug

Yes

Countries

• United States
• Brazil
• China
• Haiti
• India
• Kenya
• Malawi
• Peru
• South Africa
• Thailand
• Uganda
• Vietnam
• Zimbabwe

Study Locations