Ultra Curto (Ultra Short) TB Prevention Therapy
Primary Purpose
Tuberculosis
Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Rifapentine 600 mg and INH 300 mg
Rifapentine 900 mg and INH 900 mg
Sponsored by
About this trial
This is an interventional prevention trial for Tuberculosis
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 <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
Sites / Locations
- Fundacao de Medicina Tropical Doutor HeitorRecruiting
- NAPDOTRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rifapentine 600 mg and Isoniazid 300 mg
Rifapentine 900 mg and Isoniazid 900 mg
Arm Description
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04703075
First Posted
January 7, 2021
Last Updated
June 2, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT04703075
Brief Title
Ultra Curto (Ultra Short) TB Prevention Therapy
Official Title
Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rifapentine 600 mg and Isoniazid 300 mg
Arm Type
Experimental
Arm Description
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
Arm Title
Rifapentine 900 mg and Isoniazid 900 mg
Arm Type
Active Comparator
Arm Description
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Rifapentine 600 mg and INH 300 mg
Intervention Description
Participants will receive Rifapentine 600 mg and INH 300 mg
Intervention Type
Drug
Intervention Name(s)
Rifapentine 900 mg and INH 900 mg
Intervention Description
Participants will receive Rifapentine 900 mg and INH 900mg
Primary Outcome Measure Information:
Title
Number of participants who complete treatment with >90% adherence
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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 <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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz Kohler
Phone
410-614-3812
Email
bkohler@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Chaisson, MD
Phone
4109551755
Email
rchaiss@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Chaisson, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacao de Medicina Tropical Doutor Heitor
City
Manaus
State/Province
AM
ZIP/Postal Code
69040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Spener, MD
Phone
+55 92 94554849
Email
renataspenergomas@gmail.com
Facility Name
NAPDOT
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
22450-221
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamile Garcia
Phone
+55 21 980020515
Email
jamiles.garcia@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Ultra Curto (Ultra Short) TB Prevention Therapy
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