Prevention of tuberculosis (TB) with 3 months of isoniazid and rifapentine in people living with HIV and in child household contacts of TB patients

Not Applicable

Not yet recruiting

• Conditions: Prevention of TB in Children aged less than 6 years who are household contacts of sputum positive pulmonary TB patients; Human immunodeficiency virus [HIV] disease,

• Registration Number: CTRI/2020/07/026305
• Lead Sponsor: ICMRNational Institute for Research in TB

Brief Summary

This demonstration study proposes the scale-up of 3 months of once-weekly isoniazid and rifapentine (3HP) as preventive therapy for tuberculosis (TB) under programmatic conditions in India. The target population for this study are People living with HIV/AIDS (PLHIV) and children aged 2 to <6 years who are household contacts of sputum positive pulmonary TB patients. The study will be conducted by five centres in India. The study outcomes include demand and uptake of 3HP, treatment completion, drug adverse effects, TB incidence and mortality. The follow-up is scheduled every month upto 3 months, at 6 and 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-09
• Last Update Posted: 2020-06-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 8250

Inclusion Criteria

• Study population: People living with HIV/AIDS (PLHIV) Child household contacts of sputum positive pulmonary TB patients treated under NTEP 1.Aged >2 years with laboratory confirmation of HIV as per the National guidelines (for PLHIV only) 2.Aged >2 years to less than 6 years (for child household contacts only) 3.No current evidence of active TB 4.Not currently on Isoniazid preventive therapy (IPT) or completion of IPT in the past 5.Not currently on anti-TB treatment or received anti-TB treatment in the past one year 6.
• Willing to provide written informed consent / parent or guardian consent for children.

Exclusion Criteria

• Study population: People living with HIV/AIDS (PLHIV) Child household contacts of sputum positive pulmonary TB patients treated under NTEP 1.Critically ill in the judgement of the Medical Officer 2.Unable to take oral medications 3.Body weight <10 Kg 4.Household contact of known MDR-TB / Rif or INH-resistant TB 5.Current or H/O seizure disorder 6.Abnormal clinically significant blood parameters prior to enrolment 7.Any social or medical condition which in the opinion of the investigator would make study participation unsafe In addition to above, in PLHIV 8.Alcohol use likely to interfere with adherence 9.On Nevirapine and or Protease Inhibitor based ART regimen, any medication known to interact with rifapentine 10.
• Peripheral neuropathy (Grade 3 or 4) 11.
• Pregnancy/lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: Scale up of 3 HP in PLHIV and Child Contacts of smear positive pulmonary TB patients will be determined by demand, uptake, treatment completion and discontinuation of preventive therapy.	Months - 1,2 and 3

Secondary Outcome Measures

Name	Time	Method
1. Feasibility in terms of barriers and facilitators for 3HP implementation.	2. Drug Adverse events - Proportion of participants with drug adverse events in those initiated on 3HP.

Trial Locations

Locations (5)

B.J.Medical College and Sassoon General Hospitals; 🇮🇳 Pune, MAHARASHTRA, India

ICMR-National AIDS Research Institute; 🇮🇳 Pune, MAHARASHTRA, India

ICMR-National Institute for Research in TB; 🇮🇳 Chennai, TAMIL NADU, India

ICMR-Regional Medical Research Institute; 🇮🇳 Khordha, ORISSA, India

National Institute of TB and Respiratory Diseases; 🇮🇳 Delhi, DELHI, India

B.J.Medical College and Sassoon General Hospitals

🇮🇳Pune, MAHARASHTRA, India

Dr Shashi Sangle

Principal investigator

020-26128000

shashisangle@yahoo.com