CompletedPhase 4

Ultra Curto (Ultra Short) TB Prevention Therapy

Brazil531 participantsStarted 2022-03-24

Plain-language 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.

Who can participate

Age range

15 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Who Complete Treatment With >90% Adherence

Timeframe: 6 months

Frequency of Targeted Adverse Events or Treatment Discontinuation for Side Effects

Timeframe: 6 months

Trial details

NCT IDNCT04703075

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-10

Results submitted2025-06-04

View on ClinicalTrials.gov More Tuberculosis trials

Who can participate

Age range

15 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.