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Safety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: A phase 1/2 open label, non-randomised, multicentre trial

The Lancet HIV Dec 14, 2018

Nachman S, et al. - In this phase 1/2 open-label multicentre trial (IMPAACT P1066), done in 43 IMPAACT network sites in the USA, South Africa, Brazil, Botswana, and Argentina, researchers investigated the long-term safety, tolerability, pharmacokinetics, and efficacy of multiple raltegravir formulations in children aged 4 weeks to 18 years with HIV-1 infection. According to the age and weight of participants, they added three formulations of open-label raltegravir—adult tablets, chewable tablets, and granules for oral suspension— to individualized optimized background therapy. Only the final selected dose of raltegravir was administered to 122 patients (63 received adult tablets, 33 chewable tablets, and 26 oral granules). Raltegravir addition to an individually optimized antiretroviral therapy regimen led to virological success at week 240 in 19 of 43 patients receiving 400 mg tablets, 24 of 31 patients receiving the chewable tablets, and 13 of 15 patients receiving oral granules. This suggests that for the treatment of HIV-1 infection, raltegravir can be used in children as young as 4 weeks, with the expectation of long-term safety and efficacy. However, they recommend practicing caution when using raltegravir among older children who had previous extensive antiretroviral therapy.
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