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Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349

Trial Profile

Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2023

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At a glance

  • Drugs Rifapentine (Primary) ; Ethambutol; Isoniazid; Moxifloxacin; Pyrazinamide; Rifampicin
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ACTG Study A5349; TBTC Study 31
  • Most Recent Events

    • 24 Mar 2023 Results of population pharmacokinetic analysis of INH in patients with drug-susceptible TB using data from S31/A5349, presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 24 Mar 2023 Results deriving data from NCT02410772; developing Mathematical Model for Selecting Regimen Composition and Duration Based on Phenotype for Patients with Drug-Susceptible Tuberculosis, presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 24 Mar 2023 Results assessing PK-safety relationships and perform simulations to inform who can benefit from optimized rifapentine doses, presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
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