Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 8, 2018

Primary Completion Date

August 19, 2019

Study Completion Date

August 19, 2019

Conditions
Malaria, Vivax
Interventions
DRUG

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.

DRUG

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.

DRUG

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).

DRUG

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).

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (1)

10430

GSK Investigational Site, Jakarta

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Medicines for Malaria Venture

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT02802501 - Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria | Biotech Hunter | Biotech Hunter