ISRCTN ISRCTN04379941
DOI https://doi.org/10.1186/ISRCTN04379941
Secondary identifying numbers 12/0426
Submission date
19/10/2012
Registration date
26/02/2013
Last edited
25/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Within the UK, completion rates for latent tuberculosis infection (LTBI) treatment regimens are known to be poor. A recent paper described a novel LTBI treatment regimen of Rifapentine/Isoniazid with high completion rates. The aim of this study is to compare completion rates between this novel regimen and a Rifinah regimen and provide useful data to inform future practice. The value for money of this approach is assessed.

Who can participate?
Male or non-pregnant, non-nursing, females, aged between 16 and 65, who test positive for LTBI but do not have active tuberculosis disease

What does the study involve?
Participants are randomly allocated to either twice daily Rifinah or weekly Rifapentine and Isoniazid for 3 months. Treatment adherence and adverse reactions are monitored every month through clinic appointments and for 1 month after treatment completion.

What are the possible benefits and risks of participating?
Participants could reduce their risk of developing active tuberculosis by being treated. Possible side effects include hepatoxicity (damage of the liver). These would be monitored during the study and the treatment would be stopped if clinically indicated.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
May 2014 to May 2015

Who is funding the study?
Department of Health (UK)

Who is the main contact?
Prof. Ibrahim Abubakar
i.abubakar@ucl.ac.uk

Contact information

Prof Ibrahim Abubakar
Scientific

University College London
Research Department of Infection and Population Health
4th floor Mortimer Market, off Capper Street
London
WC1E 6JB
United Kingdom

ORCiD logoORCID ID 0000-0002-0370-1430
Phone +44 (0)20 7679 0954
Email i.abubakar@ucl.ac.uk

Study information

Study designPilot of a randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe HALT LTBI study: Phase IV multi-site, unblinded, randomised trial of prophylactic Rifapentine/Isoniazid versus Rifampicin/Isoniazid (Rifinah) for latent tuberculosis infection (LTBI)
Study objectivesCompletion rates for individuals treated with Rifapentine/Isoniazid will be higher than for those treated with Rifinah.
Ethics approval(s)NRES Committee London, Brent, 29/11/2013, ref: 13/LO/1666
Health condition(s) or problem(s) studiedLatent tuberculosis infection
InterventionRandom allocation to either Rifinah (300mg Rifampicin plus 150mg Isoniazid, two daily) or Rifapentine and Isoniazid (3 months, 12 weekly doses); monthly follow-up for the duration of treatment and one month after treatment completion.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Rifampicin, isoniazid, rifapentine
Primary outcome measure1. Completion of treatment regimen
2. Associated health economics to determine cost effectiveness of the intervention
Secondary outcome measuresAdverse effects of treatment for LTBI
Overall study start date01/05/2014
Completion date30/06/2017

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Total final enrolment52
Key inclusion criteria1. Male or non-pregnant, non-nursing, female adults aged between 16 years 0 days and 64 years 364 days at enrolment
2. Individuals at high risk for developing tuberculosis but without evidence of active tuberculosis. High-risk is defined on the basis of a positive Interferon Gamma Release Assay (IGRA)
3. People with no evidence of active tuberculosis who have a positive IGRA as defined above
4. Willing and able to provide written informed consent
Key exclusion criteriaCurrent exclusion criteria as of 31/03/2014:
1. Patients unable to give consent
2. Pregnant or breastfeeding women
3. Patients whose weight is under 45 kg
4. Allergies to any of the study drugs or excipients contained in preparations of these medicines
5. Patients requiring medications that cannot be safely taken with the study drugs (see Appendix 2)
6. Any medical condition deserving priority of treatment (such as: porphyria, malabsorption syndromes, Clostridium difficile-associated diarrhoea and other conditions)
7. HIV infection
8. Individuals with known liver disease, defined as LFT (ALT/AST/bilirubin) over upper limit of normal (ULN) at baseline (one abnormal value prevents the patient from participating in the study)
9. Clinical diagnosis of cirrhosis (jaundice, hematemesis, ascites or previous episodes of liver encephalopathy)
10. Chronic/active hepatitis B or hepatitis C virus infection
11. High-risk drinking, according to the Department of Health criteria (regularly drinking more than 8 units a day or 50 units a week for men; regularly drinking more than 6 units a day or 35 units a week for women)
12. Previous treatment for TB or LTBI
13. Individuals who would usually be offered LTBI treatment under Directly Observed Therapy (DOT) because of their mental or social disabilities
14. Use of another experimental investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment

Previous exclusion criteria:
1. Females of childbearing potential must be willing to use an effective method of contraception
2. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment
3. Females must not be breastfeeding
4. Allergies to Rifapentine, Isoniazid, Rifampicin or excipients contained in the preparations of these medicines
5. Patients requiring medications that cannot be safely taken with the study drugs
6. High risk drinking, according to the Department of Health criteria
7. Those who are HIV positive
8. Individuals who already have significant liver disease
9. Those who would not be eligible for LTBI treatment under the American Thoracic Society Criteria
10. Individuals who would usually be offered LTBI treatment under Directly Observed Therapy (DOT)
Date of first enrolment01/05/2014
Date of final enrolment31/05/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University College London
London
WC1E 6JB
United Kingdom
Barts Health, Newham University Hospital
London
E13 8SL
United Kingdom
The Royal Free London NHS Foundation Trust
London
NW3 2QG
United Kingdom

Sponsor information

University College London (UK)
University/education

c/o Anne Marie Downey
Joint Research Office
1st Floor Maple House (Suite A)
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

Website http://www.ucl.ac.uk/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

Department of Health Policy Research Programme (UK) ref: 015/0306

No information available

Results and Publications

Intention to publish date30/06/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal within one year of end of study (by 30/06/2018).
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 21/01/2021 25/01/2021 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

25/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
23/10/2017: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/05/2015 to 30/06/2017.
2. Publication and dissemination plan and IPD sharing statement added.
31/03/2014: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/04/2013 to 01/05/2014.
2. The overall trial end date was changed from 30/09/2015 to 31/05/2015.