The HALT Latent Tuberculosis study

Phase 4

Completed

• Conditions: atent tuberculosis infection; Infections and Infestations; Tuberculosis

• Registration Number: ISRCTN04379941
• Lead Sponsor: niversity College London (UK)

Brief Summary

2021 results in https://pubmed.ncbi.nlm.nih.gov/33478428/ (added 25/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-26
• Study Completion: 2017-06-30
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. 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

Exclusion Criteria

Current 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Completion of treatment regimen<br> 2. Associated health economics to determine cost effectiveness of the intervention<br>

Secondary Outcome Measures

Name	Time	Method
Adverse effects of treatment for LTBI