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Taima TB: 3HP Study

Primary Purpose

Tuberculosis

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

3HP

About this trial

This is an interventional prevention trial for Tuberculosis

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or non-pregnant, non-nursing females between the ages of 2-65 years
LTBI diagnosis as per Canadian TB Standards using either the Tuberculin Skin Test (TST) or the Interferon Gamma Release Assay (IGRA)
Children 2-5 years with negative TSTs who have been in close contact with a case of active TB disease recently
Able and willing to provide fully informed consent or parent/guardian able to provide consent

Exclusion Criteria:

Suspected or confirmed active TB disease
Known allergies to any of the study medications by participant self-report
Female participants of childbearing potential who:
1. have a positive pregnancy test at screening, or
2. are not willing to use a reliable method of barrier contraception during the study, or
3. are breastfeeding
Unable/unwilling to substitute medications with drug interactions with 3HP, including :
1. hormonal contraception
2. HIV infected participants who are on anti-retroviral drugs
3. other drugs that interact with 3HP (see Table 1)
Known contact with an INH or rifampin resistant case
Weight < 10 kg
Evidence of possible liver damage defined by an aspartate transaminase (AST) level that is more than 3x the upper limit of normal in an asymptomatic patient
Porphyria reported by patient
Inability to adhere to protocol.
Patients may be excluded from the study for other reasons, at the investigator's discretion with detailed documentation.

Sites / Locations

The Ottawa Hospital - General Campus

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3HP

Arm Description

The interrupted time series design aims to collect data at multiple time points before (standard regimen) and after the introduction of the new 3HP regimen (interruption) to detect if a significant increase in the number of completions has occurred with the new regimen

Outcomes

Primary Outcome Measures

Completion of treatment

Participants who start and complete treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT02689089

First Posted

February 18, 2016

Last Updated

March 20, 2020

Sponsor

Ottawa Hospital Research Institute

Collaborators

Government of Nunavut, Government of Canada

1. Study Identification

Unique Protocol Identification Number

NCT02689089

Brief Title

Taima TB: 3HP Study

Official Title

Acceptability and Completion Rates of a New 12 Dose Treatment (3 Month) Compared to the Standard Treatment for Latent TB Infection Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

November 28, 2016 (Actual)

Primary Completion Date

August 15, 2019 (Actual)

Study Completion Date

August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

Collaborators

Government of Nunavut, Government of Canada

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase IV clinical study trial will be conducted among persons who require treatment for LTBI treatment in Iqaluit, Nunavut and Ottawa, Ontario. The primary objective of this study is to compare the proportion of people who complete directly observed prophylactic treatment (DOPT) using the new 3HP regimen to the current standard of 9 months INH.

Detailed Description

The treatment of latent tuberculosis infection (LTBI) is a vital component of the overall strategy to reduce TB in a population. Treatment prevents ongoing transmission in communities by preventing the development of active TB disease. The current international standard for the treatment of LTBI is 9 months of Isoniazid (INH). Adherence to this lengthy regimen is one of the greatest impediments to treatment. A recent multi-centered, multi-national randomized control non inferiority trial with approximately 4,000 patients per arm demonstrated that Rifapentine and INH (3HP) given once weekly for a total of 12 doses was as effective as 9 months (252 doses) of daily INH treatment for LTBI.(1) These findings were also replicated in the pediatric population through a pediatric cohort (n=905 eligible participants) nested within the multi-centered international randomized controlled trial with children between ages 2-17 treated with 3HP compared to the INH standard for LTBI.(2) The efficacy and safety of this new regimen have been established. Rifapentine was approved by the United States Food and Drug Administration (FDA) in December of 2014 for the treatment of LTBI but is not yet approved in Canada. The shortened treatment course could increase the number of people who complete LTBI treatment which could lead to a decrease in active TB cases.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3HP

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

3HP

Other Intervention Name(s)

rifapentine, Priftin

Intervention Description

An interrupted time series study design will be used to determine if the introduction of the 3HP regimen will result in more people completing LTBI treatment compared to the standard of 9 months INH twice weekly.

Primary Outcome Measure Information:

Title

Completion of treatment

Description

Participants who start and complete treatment

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or non-pregnant, non-nursing females between the ages of 2-65 years LTBI diagnosis as per Canadian TB Standards using either the Tuberculin Skin Test (TST) or the Interferon Gamma Release Assay (IGRA) Children 2-5 years with negative TSTs who have been in close contact with a case of active TB disease recently Able and willing to provide fully informed consent or parent/guardian able to provide consent Exclusion Criteria: Suspected or confirmed active TB disease Known allergies to any of the study medications by participant self-report Female participants of childbearing potential who: have a positive pregnancy test at screening, or are not willing to use a reliable method of barrier contraception during the study, or are breastfeeding Unable/unwilling to substitute medications with drug interactions with 3HP, including : hormonal contraception HIV infected participants who are on anti-retroviral drugs other drugs that interact with 3HP (see Table 1) Known contact with an INH or rifampin resistant case Weight < 10 kg Evidence of possible liver damage defined by an aspartate transaminase (AST) level that is more than 3x the upper limit of normal in an asymptomatic patient Porphyria reported by patient Inability to adhere to protocol. Patients may be excluded from the study for other reasons, at the investigator's discretion with detailed documentation.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gonzalo G Alvarez, MD

Organizational Affiliation

Ottawa Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital - General Campus

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Institutional approval would be required from research collaborators for the release of this data.

Citations:

PubMed Identifier

22150035

Citation

Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875.

Results Reference

background

PubMed Identifier

25580725

Citation

Villarino ME, Scott NA, Weis SE, Weiner M, Conde MB, Jones B, Nachman S, Oliveira R, Moro RN, Shang N, Goldberg SV, Sterling TR; International Maternal Pediatric and Adolescents AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Treatment for preventing tuberculosis in children and adolescents: a randomized clinical trial of a 3-month, 12-dose regimen of a combination of rifapentine and isoniazid. JAMA Pediatr. 2015 Mar;169(3):247-55. doi: 10.1001/jamapediatrics.2014.3158. Erratum In: JAMA Pediatr. 2015 Sep;169(9):878.

Results Reference

background

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Taima TB: 3HP Study

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