Shorter Treatment for Minimal TB in Children (SHINE)

Post Date: 
2017-01-17
   |   
Countries: 
India
   |   
Clinical Sites: 
BJGMC
Summary: 
This study was terminated effective 5/29/2022
 
This is a multicountry study being conducted in India, South Africa, Uganda, and Zambia. The principal objective is to determine whether the standard 6 month regimen (8 weeks HRZ(E) followed by 16 weeks HR) can be reduced with similar efficacy, to 4 months (8 weeks HRZ(E) followed by 8 weeks HR), in HIV-infected and uninfected African and Indian children with minimal TB, using recently revised dosing guidelines for anti-TB drugs in children.
 
Other objectives are:
  1. To determine whether the higher WHO-recommended doses of daily first-line anti-TB drugs, given as new WHO-recommended, fixed-dose combination (FDC) dispersible tablets, and prescribed according to weight bands, result in appropriate drug exposures when compared with historical paediatric and adult pharmacokinetic (PK) data (PK substudy 1)
  2. To determine in HIV-infected children, whether currently recommended adjusted strategies and doses of antiretroviral drugs (ARVs) can appropriately overcome the effect of R at the new higher doses (PK substudy 2)
Staff: 
Vidya Mave, MD, MPH
Collaborators: 
  • MRC Clinical Trials Unit
  • National Institute for Research in Tuberculosis, Chennai, India
  • MU-JHU Care, Ltd, Kampala, Uganda
  • Stellenbosch University, South Africa
  • University Teaching Hospital, Lusaka, Zambia