NCT04703075

Ultra Curto (Ultra Short) TB Prevention Therapy

Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 531 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 15 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Tuberculosis (TB) is the leading infectious killer globally and a major cause of illness and suffering. The World Health Organization has prioritized TB preventive therapy (TPT) for people with latent TB infection (LTBI) as a key strategy for controlling the epidemic. Prevention of TB with isoniazid preventive therapy (IPT) is effective and reduces morbidity and mortality, and has been the mainstay of TB prevention for decades. But for an intervention with an excellent evidence of efficacy, global uptake has been abysmal. Completion rates for IPT when it is administered are poor (Gillespie 2008; Durovni 2010), with a large proportion of patients unable to complete treatment (McClintock 2017; Sterling 2011). While uptake is influenced by a variety of factors, a critical element has been the duration of IPT, with adherence falling sharply over time in clinical trials and practice. Shorter course regimens have a much higher completion rate and are more acceptable to patients, clinicians, and programs.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Rifapentine 600 mg and INH 300 mg	Participants will receive Rifapentine 600 mg and INH 300 mg
DRUG	Rifapentine 900 mg and INH 900 mg	Participants will receive Rifapentine 900 mg and INH 900mg

Timeline

• Start date: 2022-03-24
• Primary completion: 2024-06-10
• Completion: 2024-06-10
• First posted: 2021-01-11
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

2 sites across 1 country: Brazil