TuberculosisPhase 4NCT04703075
Ultra Curto (Ultra Short) TB Prevention Therapy
A Phase 4 study testing Rifapentine 600 mg and INH 300 mg and Rifapentine 900 mg and INH 900 mg in people with Tuberculosis, run by Johns Hopkins University at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Rifapentine 600 mg and INH 300 mg and Rifapentine 900 mg and INH 900 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 531 participants
- Where
- 2 sitesBrazil
- Study dates
- 24 Mar 2022to 10 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Fundacao de Medicina Tropical Doutor Heitor
Manaus, Amazonas, 69040-000
NAPDOT
Rio de Janeiro, Rio de Janeiro, 22450-221
About this study
Official title: Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
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.
Read the 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
- Being tested
- Rifapentine 600 mg and INH 300 mg, Rifapentine 900 mg and INH 900 mg
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifapentine 600 mg and INH 300 mgDrug
Participants will receive Rifapentine 600 mg and INH 300 mg
Rifapentine 900 mg and INH 900 mgDrug
Participants will receive Rifapentine 900 mg and INH 900mg
| Study group | Role | What they receive |
|---|---|---|
| Arm A: 1HP | Experimental | Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks. Receives: Drug: Rifapentine 600 mg and INH 300 mg |
| Arm B: 3HP | Active comparator | Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks. Receives: Drug: Rifapentine 900 mg and INH 900 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete Treatment With >90% Adherence
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.
Measured: 6 months
Frequency of Targeted Adverse Events or Treatment Discontinuation for Side Effects
Participants with targeted adverse event grade 2 or more or discontinuing treatment for any side effect.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start24 Mar 2022
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Chaisson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703075
- Sponsor's protocol ID
- IRB00284317
- Other IDs
- U01AI152961
- Status last verified
- Jun 2025
- First submitted
- 7 Jan 2021
- Last updated
- 19 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Durovni B, Cordeiro-Santos M, Cavalcante SC, Spener-Gomes R, Garcia J, Cohn S, Saraceni V, Kohler B, Moulton LH, Brito da Souza A, Berihun A, Marzinke M, Chaisson RE; Ultra Curto Study Team. 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 Feb 10;23(2):e1004758. doi: 10.1371/journal.pmed.1004758. eCollection 2026 Feb.
PubMed 41666121
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
- ClinicalTrials.gov ID
- NCT04703075
- Acronym / sponsor ID
- IRB00284317
- Conditions
- Tuberculosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Sanofi
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 19 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A: 1HP | Experimental | Drug: Rifapentine 600 mg and INH 300 mgParticipants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks. |
| Arm B: 3HP | Active comparator | Drug: Rifapentine 900 mg and INH 900 mgParticipants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks. |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifapentine 600 mg and INH 300 mgParticipants will receive Rifapentine 600 mg and INH 300 mg | Drug | Arm A: 1HP |
| Rifapentine 900 mg and INH 900 mgParticipants will receive Rifapentine 900 mg and INH 900mg | Drug | Arm B: 3HP |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41666121Durovni B, Cordeiro-Santos M, Cavalcante SC, Spener-Gomes R, Garcia J, Cohn S, Saraceni V, Kohler B, Moulton LH, Brito da Souza A, Berihun A, Marzinke M, Chaisson RE; Ultra Curto Study Team. 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 Feb 10;23(2):e1004758. doi: 10.1371/journal.pmed.1004758. eCollection 2026 Feb.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Chaisson, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifapentine 600 mg and INH 300 mg and Rifapentine 900 mg and INH 900 mg in people with Tuberculosis, run by Johns Hopkins University at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Complete Treatment With >90% Adherence (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.