150
Participants
Start Date
April 8, 2018
Primary Completion Date
August 19, 2019
Study Completion Date
August 19, 2019
Tafenoquine
This intervention is provided as tablet containing 150 mg of tafenoquine. Two tablets of this formulation will be administered orally with water as a single dose after a meal. Dose will be taken at least 3 hours after DHA-PQP.
Matched-Placebo for Tafenoquine
This intervention contains tafenoquine matched-placebo. Two tablets of this formulation will be administered orally with water as a single dose after a meal. Dose will be taken at least 3 hours after DHA-PQP.
Primaquine
This intervention is provided as over-encapsulated tablet containing 15 mg of primaquine. One capsule of this formulation will be administered orally with water as a single dose after a meal for 14 days. Dose will be taken at least 3 hours after DHA-PQP (Days 1, 2 and 3).
Matched-Placebo for Primaquine
This intervention contains primaquine matched-placebo. One capsule of this formulation will be administered orally with water as a single dose after a meal for 14 days. Dose will be taken at least 3 hours after DHA-PQP (Days 1, 2 and 3).
Dihydroartemisinin-piperaquine (DHA-PQP)
This formulation is provided as tablet containing 320 mg of piperaquine tetrasphosphate (as the tetrahydrate; PQP) and 40 mg dihydroartemisinin (DHA). This tablet will be administered orally as single dose for 3 days. For subjects weighing \<75 kg, 3 tablets will be administered per day. For subjects weighing \>=75 kg, 4 tablets will be administered per day. Dose will be taken at least 3 hours after last food intake. No food will be allowed for at least 3 hours after dosing.
ACT plus PQ (Rescue medication)
Subjects with relapse during the 180 day follow up period will be given an ACT plus PQ 0.5 mg/kg for 14 days as rescue medication.
PQ (End of study treatment)
Subjects who do not relapse during the study will receive PQ 0.5mg/kg for 14 days at the end of the study.
GSK Investigational Site, Jakarta
Lead Sponsor
Medicines for Malaria Venture
OTHER
GlaxoSmithKline
INDUSTRY