Phase 4
N=500
Ultra Curto (Ultra Short) TB Prevention Therapy
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT04703075 ↗Enrolled (actual)
500
Serious AEs
0.6%
Results posted
Jun 2025
Primary outcome: Primary: Number of Participants Who Complete Treatment With >90% Adherence — 223; 211 Participants — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rifapentine 600 mg and INH 300 mg (Drug); Rifapentine 900 mg and INH 900 mg (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Complete Treatment With >90% Adherence |
223; 211 | 0.07 |
| PRIMARY Frequency of Targeted Adverse Events or Treatment Discontinuation for Side Effects |
40; 26 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT04703075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.