Treatment Success and Safety of 4 Weeks of Daily Rifapentine and Isoniazid (1HP) vs. 12 Weeks of Weekly Rifapentine and Isoniazid (3HP) for Prevention of Tuberculosis in HIV-uninfected Individuals (1v3HP for TPT in HIV-uninfected Individuals)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Tuberculosis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm A (n=250): Experimental arm. Rifapentine 600 mg daily and isoniazid 300 mg daily for 4 weeks. Arm B (n=250): Control arm. Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 15 years and 90 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04703075
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Investigators
- Principal Investigator: Richard Chaisson, MD Johns Hopkins University
Get Well Soon