Ultra Curto (Ultra Short) TB Prevention Therapy

NCT04703075 | Completed Phase 4 Results DMC

• 2 other identifiers: IRB00284317U01AI152961
• Study Type: interventional
• Target: 531
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Arm A: 1HP

EXPERIMENTAL

Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.

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.

Drug: Rifapentine 900 mg and INH 900 mg

Interventions

Rifapentine 600 mg and INH 300 mg DRUG

Participants will receive Rifapentine 600 mg and INH 300 mg

Arm A: 1HP

Rifapentine 900 mg and INH 900 mg DRUG

Participants will receive Rifapentine 900 mg and INH 900mg

Arm B: 3HP

Eligibility Criteria

• Age: 15 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Sanofi: collaborator

Study Sites (2)

Fundacao de Medicina Tropical Doutor Heitor

Manaus, Amazonas, 69040-000, Brazil

Location

NAPDOT

Rio de Janeiro, Rio de Janeiro, 22450-221, Brazil

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

rifapentine; Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Maria Beatriz Kohler, Senior Research Nurse
• Organization: Johns Hopkins University School of Medicine

bkohler@jhmi.edu

4104048921

Study Officials

• Richard Chaisson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: March 24, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Locations

BR (2)