Taima TB: 3HP Study

NCT02689089 | Completed Phase 4 DMC

• 1 other identifier: 20160044-01H
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Completion of treatment

  Participants who start and complete treatment

  3 months

Study Arms (1)

3HP

OTHER

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

Drug: 3HP

Interventions

3HP DRUG

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.

Also known as: rifapentine, Priftin

3HP

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Government of Nunavut: collaborator
• Government of Canada: collaborator

Study Sites (1)

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (2)

• 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.

  PMID: 22150035 BACKGROUND

• 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.

  PMID: 25580725 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Interventions

rifapentine

Condition Hierarchy (Ancestors)

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

Study Officials

• Gonzalo G Alvarez, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: November 28, 2016
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)