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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI152961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Sanofi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 1HP | Experimental | Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks. |
|
| Arm B: 3HP | Active Comparator | Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifapentine 600 mg and INH 300 mg | Drug | Participants will receive Rifapentine 600 mg and INH 300 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Chaisson, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacao de Medicina Tropical Doutor Heitor | Manaus | Amazonas | 69040-000 | Brazil | ||
| NAPDOT |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41666121 | Derived | 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. |
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531 people signed consent to be screened for eligibility. 31 people did not meet the eligibility criteria. The reasons were: Risk for Bad Outcome n=8, Active TB n=5, Withdrew Consent n=3, Pregnant n=1, Neutropenia n=2, AST/ALT > 3 times ULN n=8, HIV infection n= 1, Drug-Drug Interaction n=2, Past TB-TPT treatment n=1. 500 people were assigned to a treatment group in the study. 249 were Randomized to Arm A:1HP. 251 were randomized to Arm B: 3HP
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: 1HP | Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks. Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg |
| FG001 | Arm B: 3HP | Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks. Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Thirty one participants were not eligible and not randomized to the arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: 1HP | Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks. Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg |
| BG001 | Arm B: 3HP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months |
|
Up to 6 months
Targeted adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: 1HP | Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks. Rifapentine 600 mg and INH 300 mg: Participants will receive Rifapentine 600 mg and INH 300 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | Protocol | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatotoxicity | Hepatobiliary disorders | Protocol | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Beatriz Kohler, Senior Research Nurse | Johns Hopkins University School of Medicine | 4104048921 | bkohler@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2023 | Jun 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2023 | May 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C018421 | rifapentine |
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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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.
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| Rifapentine 900 mg and INH 900 mg | Drug | Participants will receive Rifapentine 900 mg and INH 900mg |
|
| Rio de Janeiro |
| Rio de Janeiro |
| 22450-221 |
| Brazil |
| Physician Decision |
|
| Moved |
|
| Index INH Resistant |
|
| Lack of Efficacy |
|
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 249 |
| 1 |
| 249 |
| 13 |
| 249 |
| EG001 | Arm B: 3HP | Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks. Rifapentine 900 mg and INH 900 mg: Participants will receive Rifapentine 900 mg and INH 900mg | 0 | 251 | 2 | 251 | 10 | 251 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |