Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial (TBTC Study 31 and ACTG Study A5349)
Sponsor - U.S. Centers for Disease Control & Prevention (200-2009-32598)
Principal Investigator – John L. Johnson, MD, CWRU
|Type of Study||Phase 3 Clinical Trial|
|Design||Multi-center, randomized controlled, open label , 3-arm, non-inferiority trial|
|Project Site||Kampala, Uganda|
|Sample Size||2500 participants, all study sites, enrolling individuals with newly diagnosed, previously untreated pulmonary tuberculosis|
|Study Period||Individual participant duration of follow-up:
Goal of Study:
To identify an improved treatment regimen to shorten treatment duration for drug susceptible strains, efficacious against resistant strains that could overall reduce the incidence of TB worldwide.
- To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
- To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
- To evaluate the safety of the investigational regimens
- To evaluate the tolerability of the investigational regimens
- To collect and assess biospecimens from consenting participants for the purpose of research on discovery and validation of TB biomarkers
- To determine the correlation of mycobacterial and clinical markers with time to culture conversion, culture status at completion of eight weeks of treatment, treatment failure, and relapse.
- To conduct a pharmacokinetic/pharmacodynamic (PK/PD) study of the test drugs. The main objectives of the PK/PD study are to characterize study drug PK parameters and to determine relationships between treatment outcomes and PK parameters.
- To evaluate the pharmacokinetics of efavirenz-based antiretroviral treatment among patients with TB/HIV co-infection taking efavirenz-based combination antiretroviral therapy and TB treatment with rifapentine