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

ICMRNational Institute for Research in TB0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

ICMRNational Institute for Research in TB