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Principal Investigator

Prof. Inge Sutanto, MD, PhD

Responsible Investigator

Prof. J. Kevin Baird, Phd, FASTMH

Co-Investigators

    Sponsor:  GlaxoSmithKline

    Funder: Medicine for Malaria Venture and Bill and Melinda Gates Foundation

    Study period: April 2018 - December 2019

    Background

    This trial represents a series of collaborations with the Indonesian Army Health Directorate in Jakarta via their memorandum of understanding with EIMB regarding assistance in building capacities in military medical research. This new trial, as with the two prior since 2010, capitalizes a unique ability to definitively identify recurrent patent infections by Plasmodium vivax as relapses, and following anti-relapse treatment, as therapeutic failures. We can do this because the soldiers are infected while heavily exposed in eastern Indonesia and return to where reinfection is highly improbable (see map below). The trials occur in army bases on Java and the soldiers are followed for 6-12mo. 

    Forty years ago the US Army invented a drug called tafenoquine, an 8-aminoquinoline drug intended to replace primaquine as a more convenient (single dose vs. 14 daily doses) hypnozoitocidal (anti-relapse) therapy. Only this year did the US FDA approve tafenoquine for this use in combination with chloroquine for radical cure of vivax malaria. Resitance to chloroquine by P. vivax in Indonesia means that radical cure cannot be used, but tafenoquine must be combined with Indonesia’s first line treatment against P. vivax, dihydroartemisinin piperaquine.

    GSK and their financial and technical supporters at the Bill and Melinda Gates Foundation (Seattle) and the Medicines for Malaria Venture (Geneva) agreed to fund and sponsor a first look at tafenoquine in combination with a modern artemisinin-combined treatment for radical cure of acute and latent vivax malaria in Indonesia. After prolonged negotiation with the Indonesian food and drug regulator (BPOM, Badan Permirksa Obat dan Makanan), GSK plans to file for registration of tafenoquine and dihydroartemisinin for radical cure of vivax malaria in Indonesia using the results of this trial (making it a tightly monitored and regulated pivotal trial). 

    Objective

    • To determine the efficacy of tafenoquine co-administered with DHA-PQP for the radical cure of P. vivax malaria, relative to DHA-PQP
    • To characterize the efficacy of tafenoquine relative to primaquine when co-administered with DHA-PQP.
    • To determine the efficacy of tafenoquine co-administered with DHA-PQP relative to DHA-PQP alone at four months.
    • To determine the blood stage efficacy of tafenoquine in subjects with P.vivax malaria when co-administered with DHA-PQP.
    • To assess the safety of tafenoquine in subjects with P. vivax malaria when coadministered with DHA-PQP.
    • To evaluate the pharmacokinetics of tafenoquine when co-administered with DHA-PQP in adult subjects with P.vivax malaria.

    Related unit(s):

    Coordinator: John Kevin Baird