Ultra Curto (Ultra Short) TB Prevention Therapy

Phase 4 Completed 531 enrolled Johns Hopkins University National Institute of Allergy and Infectious Diseases (NIAID) · collab Sanofi · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.

Timeline

Start: 2022-03-24
Primary completion: 2024-06-10
Completion: 2024-06-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A: 1HP vs Arm B: 3HP; p = 0.07; Risk Difference (RD) 5.5; Chi-squared, Corrected NCT04703075 ↗

Publications

Durovni B, Cordeiro-Santos M, Cavalcante SC, Spener-Gomes R, Garcia J, Cohn S, Saraceni V, Kohler B, Moulton LH, Brito da Souza A, Berihun A, Marzinke M, Chaisson RE; Ultra Curto Study Team. Acceptability and safety of one versus three months of rifapentine and isoniazid to prevent tuberculosis in people exposed in the household or workplace in Brazil: The Ultra-Curto randomized controlled trial. PLoS Med. 2026 Feb 10;23(2):e1004758. doi: 10.1371/journal.pmed.1004758. eCollection 2026 Feb.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isoniazid	Small molecule	300 mg	—
Subject	Isoniazid	Small molecule	900 mg	—
Subject	Rifapentine	Small molecule	600 mg	—
Subject	Rifapentine	Small molecule	900 mg	—