| CTRI Number |
CTRI/2020/07/026305 [Registered on: 02/07/2020] Trial Registered Prospectively |
| Last Modified On: |
27/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevention of tuberculosis (TB) with 3 months of isoniazid and rifapentine in people living with HIV and in child household contacts of TB patients |
|
Scientific Title of Study
|
Scaling up short course TB preventive regimen containing Isoniazid and Rifapentine given once-weekly for three months (3HP) among People Living with HIV/AIDS (PLHIV) and child contacts of sputum positive pulmonary TB patients in India: A demonstration project |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srikanth Tripathy |
| Designation |
Director In Charge |
| Affiliation |
ICMR National Institute for Research in TB |
| Address |
No 1 Mayor Sathyamoorthy road
Chetpet
Chennai 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
044-28369535 |
| Fax |
|
| Email |
directornirt@nirt.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VV Banurekha |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute for Research in TB |
| Address |
No 1 Mayor Sathyamoorthy road
Chetpet
Chennai 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
044-28369534 |
| Fax |
|
| Email |
bhannu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VV Banurekha |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute for Research in TB |
| Address |
No 1 Mayor Sathyamoorthy road
Chetpet
Chennai 600031
Chennai
TAMIL NADU
600031
India |
| Phone |
|
| Fax |
|
| Email |
bhannu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Name: United Nations International Drug Purchasing Facility (UNITAID); Address: Global Health Campus, Chemin du Pommier 40, 1218 Le Grand-Saconnex, Switzerland |
|
|
Primary Sponsor
|
| Name |
ICMRNational Institute for Research in TB |
| Address |
No 1, Mayor Sathyamoorthy road,
Chetpet,
Chennai - 600031 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| BJMedical College and Sassoon General Hospitals |
Jai Prakash Narayan road,
Near Pune Railway station,
Pune – 411001
|
| ICMRNational AIDS Research Institute |
Plot No:73, G Block,
MIDC, Bhosari,
Pune – 411026
|
| ICMRRegional Medical Research Institute |
NALCO Nagar,
Chandrasekharpur
Bhubaneswar - 751 023
Odisha
|
| National Institute of TB and Respiratory Diseases |
Sri Aurobindo Marg,
Near Qutub Minar,
New Delhi – 110030
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shashi Sangle |
B.J.Medical College and Sassoon General Hospitals |
Jai Prakash Narayan road,
Near Pune Railway station,
Pune – 411001
Pune
MAHARASHTRA |
020-26128000
shashisangle@yahoo.com |
| Dr Manisha Ghate |
ICMR-National AIDS Research Institute |
Plot No 73 G Block
MIDC Bhosari
Pune 411026
Pune
MAHARASHTRA |
9284793972
mghate@nariindia.org |
| Dr Srikanth Tripathy |
ICMR-National Institute for Research in TB |
No 1 Mayor Sathyamoorthy road
Chetpet
Chennai 600031
Chennai
TAMIL NADU |
044-28369535
directornirt@nirt.res.in |
| DrSanghamitra Pati |
ICMR-Regional Medical Research Institute |
NALCO Nagar
Chandrasekharpur
Bhubaneswar 751 023
Khordha
ORISSA |
674-2301322
drsanghamitra12@gmail.com |
| Dr Rohit Sarin |
National Institute of TB and Respiratory Diseases |
Sri Aurobindo Marg,
Near Qutub Minar,
New Delhi – 110030
New Delhi
DELHI |
011-26517826
drsarin@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee -BJ Medical College and Sassoon General Hospitals |
Approved |
| Ethics Committee National AIDS Research Institute |
Approved |
| NIRT-Institutional Ethics Committee |
Approved |
| NITRD-Ethics Committee |
Approved |
| RMRC-Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of TB in Children aged less than 6 years who are household contacts of sputum positive pulmonary TB patients |
| Patients |
(1) ICD-10 Condition: B20-B20||Human immunodeficiency virus [HIV] disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3HP |
3 months of once-weekly Isoniazid and Rifapentine |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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.
3. Proportion with TB incidence and mortality among those who received 3HP.
|
Months - 1,2 3,6 and 12 |
|
|
Target Sample Size
|
Total Sample Size="8250"
Sample Size from India="8250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |