TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02410772
• Date of registration: 08/02/2015
• Prospective Registration: Yes
• Primary sponsor: Centers for Disease Control and Prevention
• Public title: TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens S31/A5349
• Scientific title: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349
• Date of first enrolment: January 25, 2016
• Target sample size: 2516
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02410772
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Susan Swindells, MBBS
• Affiliation: University of Nebraska

• Name: Ekaterina V Kurbatova, MD, PhD, MPH
• Affiliation: Centers for Disease Control and Prevention

• Name: Susan Dorman, MD
• Affiliation: Medical University of South Carolina

• Name: Richard Chaisson, MD
• Affiliation: Johns Hopkins University

• Name: Payam Nahid, MD, MPH
• Affiliation: University of California at San Francisco

Key inclusion & exclusion criteria

Inclusion Criteria:

- Suspected pulmonary tuberculosis plus one or both of the following: a) at least one
sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one
sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing, with
semiquantitative result of 'medium' or 'high' and rifamycin resistance not detected.

- Age twelve (12) years or older

- A verifiable address or residence location that is readily accessible for visiting,
and willingness to inform the study team of any change of address during the treatment
and follow-up period.

- Women of child-bearing potential who are not surgically sterilized must agree to
practice a barrier method of contraception or abstain from heterosexual intercourse
during study drug treatment.

- Documentation of HIV infection status.

- For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells/mm3
based on testing performed at or within 30 days prior to screening.

- Laboratory parameters done at or within 14 days prior to screening:

- Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the
upper limit of normal

- Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit
of normal

- Serum or plasma creatinine level less than or equal to 2 times the upper limit of
normal

- Serum or plasma potassium level greater than or equal to 3.5 meq/L

- Hemoglobin level of 7.0 g/dL or greater

- Platelet count of 100,000/mm3 or greater

- For women of childbearing potential, a negative pregnancy test at or within seven (7)
days prior to screening

- Karnofsky score greater than or equal to 60

- Written informed consent

Exclusion Criteria:

- Pregnant or breast-feeding.

- Unable to take oral medications.

- Previously enrolled in this study.

- Received any investigational drug in the past 3 months.

- More than five (5) days of treatment directed against active tuberculosis within 6
months preceding initiation of study drugs.

- More than five (5) days of systemic treatment with any one or more of the following
drugs within 30 days preceding initiation of study drugs: isoniazid, rifampin,
rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin,
capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other
fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone,
para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline.

- Known history of prolonged QT syndrome.

- Suspected or documented tuberculosis involving the central nervous system and/or bones
and/or joints, and/or miliary tuberculosis and/or pericardial tuberculosis.

- Current or planned use within six months following enrollment of one or more of the
following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry
and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than
efavirenz, quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or
terfenadine. Individuals who are currently taking efavirenz-based antiretroviral
treatment or for whom initiation of efavirenz-based antiretroviral treatment is
planned within 17 weeks following enrollment may participate.

- Weight less than 40.0 kg.

- Known allergy or intolerance to any of the study medications.

- Individuals will be excluded from enrollment if, at the time of enrollment, their M.
tuberculosis isolate is already known to be resistant to any one or more of the
following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.

- Other medical conditions, that, in the investigator's judgment, make study
participation not in the individual's best interest.

- Current or planned incarceration or other involuntary detention.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Drug: rifapentine and moxifloxacin

Drug: control

Drug: rifapentine

Primary Outcome(s)

TB disease-free survival at twelve months after study treatment assignment [Time Frame: twelve months after treatment assignment]

Proportion of participants with grade 3 or higher adverse events during study drug treatment [Time Frame: four or six months]

Secondary Outcome(s)

TB disease-free survival at twelve and eighteen months after study treatment assignment assuming all losses to follow-up and non-tuberculosis deaths have a favorable outcome [Time Frame: eighteen months after study treatment assignment]

TB disease-free survival at twelve and eighteen months after study treatment assignment assuming all losses to follow-up and non-tuberculosis deaths have an unfavorable outcome [Time Frame: eighteen months after study treatment assignment]

TB disease-free survival at eighteen months after study treatment assignment [Time Frame: eighteen months after treatment assignment]

Discontinuation of assigned treatment for a reason other than microbiological ineligibility [Time Frame: four or six months]

Time to stable sputum culture conversion [Time Frame: four or six months]

Efavirenz maximum concentration, area under the time-concentration curve, and half life [Time Frame: four months]

Speed of decline of sputum viable bacilli by automated MGIT days to detection [Time Frame: four or six months]

Proportion of participants who are culture negative at eight weeks [Time Frame: eight weeks]

Secondary ID(s)

6655

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AIDS Clinical Trials Group