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Shorter Treatment for Minimal TB in Children (SHINE)
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:
- 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)
- 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)