NCT04703075CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 19 Jun 2025

Brief summary (registry, in English)

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.

Status (registry): Completed
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 531 (actual)
First submitted: 7 Jan 2021
Start date: 24 Mar 2022
Primary completion date: 10 Jun 2024
Lead sponsor: Johns Hopkins University
Diseases: Tuberculosis
NCT number: NCT04703075

What you commit to

Study type: Interventional · Phase 4
Participants enrolled: 531
From 24 Mar 2022 to the primary completion date, 10 Jun 2024
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Known intolerance of any study drug

Other illness

Documented HIV infection
Evidence of active tuberculosis on clinical exam or chest x-ray

Lab values

Active liver disease or Aspartate aminotransferase(AST)/Alanine transaminase (ALT) \>3 times upper limit of normal (ULN)
Neutropenia (ANC \<1000)

Other

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
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

Who the study is looking for

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

Age in the registry: 15 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Fundacao de Medicina Tropical Doutor Heitor Coordinator of this site? Confirm its status	Manaus	Brazil	Unknown status
NAPDOT Coordinator of this site? Confirm its status	Rio de Janeiro	Brazil	Unknown status

Related publications

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 · PMID 41666121

This page is information, not medical advice. Discuss any trial with your doctor.