Ultra Curto (Ultra Short) TB Prevention Therapy

NCT ID: NCT04703075

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 531 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2024-06-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm A: 1HP

Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.

Group Type: EXPERIMENTAL

Rifapentine 600 mg and INH 300 mg

Intervention Type: DRUG

Participants will receive Rifapentine 600 mg and INH 300 mg

Arm B: 3HP

Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Rifapentine 900 mg and INH 900 mg

Intervention Type: DRUG

Participants will receive Rifapentine 900 mg and INH 900mg

Interventions

Rifapentine 600 mg and INH 300 mg

Participants will receive Rifapentine 600 mg and INH 300 mg

Intervention Type: DRUG

Rifapentine 900 mg and INH 900 mg

Participants will receive Rifapentine 900 mg and INH 900mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Positive tuberculin skin test or interferon-gamma release assay (IGRA) test and
• Household contact of an infectious TB case within previous 90 days, defined as sleeping at least once in a residence with a person diagnosed with pulmonary TB, or
• Documented conversion of Tuberculin skin test (TST)/IGRA from negative to positive within 2 years

Exclusion Criteria

• Documented HIV infection
• Evidence of active tuberculosis on clinical exam or chest x-ray
• Known intolerance of any study drug
• Treatment for active or latent TB in the past for more than 14 days
• Known close contact to someone with INH or rifampin resistant TB
• Active liver disease or Aspartate aminotransferase(AST)/Alanine transaminase (ALT) >3 times upper limit of normal (ULN)
• Neutropenia (ANC <1000)
• Peripheral neuropathy >Grade 1 by DAIDS Grading Table
• Pregnant or breastfeeding. Women of childbearing potential must agree to use non-hormonal contraception during study treatment.
• Weight <40 kg

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Chaisson, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Fundacao de Medicina Tropical Doutor Heitor

Manaus, Amazonas, Brazil

NAPDOT

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U01AI152961

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00284317

Identifier Type: -

Identifier Source: org_study_id