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NCT Number: NCT04703075

Ultra Curto (Ultra Short) TB Prevention Therapy

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

15 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fundacao de Medicina Tropical Doutor Heitor, Manaus, Amazonas, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifapentine 600 mg and INH 300 mg

Drug

Participants will receive Rifapentine 600 mg and INH 300 mg

Rifapentine 900 mg and INH 900 mg

Drug

Participants will receive Rifapentine 900 mg and INH 900mg

Primary outcomes

  1. Number of Participants Who Complete Treatment With >90% Adherence

    Time frame: 6 months

    To compare treatment success (completion of treatment with >90% adherence) of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.

  2. Frequency of Targeted Adverse Events or Treatment Discontinuation for Side Effects

    Time frame: 6 months

    Participants with targeted adverse event grade 2 or more or discontinuing treatment for any side effect.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2021
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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