Lolipop: Lopinavir/r/ Lamivudine/ abacavir as an easy to use paediatric formulation in a phase I/II study

In partnership with DNDi, Cipla has developed a fully taste   masked ABC/3TC/LPV/r/ “4-in-1” granule formulation with good bioavailability in healthy adult volunteers. This formulation is chemically and physically stable and LPV/r is compatible with dual NRTI powders (ABC/3TC). The active components of this novel   “4-in-1” formulation   include   abacavir   (ABC), lamivudine   (3TC) and lopinavir/ritonavir (LPV/r), that have been widely used in adults and children for more than 15 years with their toxicology profile well known. The combination of various  formulations  of  lopinavir  boosted  with  ritonavir  and  abacavir  plus lamivudine constitutes one of the first line regimen recommended by WHO since 2013.This  first  study  of  the  4-in-1  in  HIV-infected  children  is  carried  out  in Uganda in HIV-infected children weighing ≥3 to <25 kg and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1. The Lopinavir/Ritonavir pellets plus dual Abacavir/Lamivudine tablets regimen which is current standard of care for young  children  (<3  years  old)  in  Uganda  was  chosen  to  provide  elements  of comparison. The cross-over design is intended to minimize the impact of intra- subject variations, in particular pharmacokinetics.

The primary objective is to estimate the population average exposure to LPV, ABC an 3TC in the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands

A phase I/II, open lebel randomized crossover pharmacokinetic, safety and accepability study of the Abacavir/Lamivudine/Lopinavir/Ritonavir Fixed-dose Combination Vs. Lopinavir/Ritonavir plus dual Abacavir/Lamivudine in HIV infected Children

DNDi, Joint Clinical Research Center Uganda, AMS-PHPT Research platform