Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse

PHASE2CompletedINTERVENTIONAL
Enrollment

851

Participants

Timeline

Start Date

April 24, 2014

Primary Completion Date

November 18, 2016

Study Completion Date

November 18, 2016

Conditions
Malaria, Vivax
Interventions
DRUG

Chloroquine 600mg

600mg Chloroquine given to each subject on Day 1 and Day2 of the trial

DRUG

Chloroquine 300mg

300mg Chloroquine given to each subject on Day 3 of the trial

DRUG

Tafenoquine 50mg

single dose 50mg Tafenoquine given to subject on treatment arm 1 on Days 1 or 2

DRUG

Tafenoquine 100mg

single dose 100mg Tafenoquine given to subject on treatment arm 2 on Days 1 or 2

DRUG

Tafenoquine 300mg

single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2

DRUG

Tafenoquine 600mg

single dose 600mg Tafenoquine given to subject on treatment arm 4 on Days 1 or 2

DRUG

Primaquine 15mg

15mg Primaquine given once daily to subject on treatment arm 5 on Days 2 to 15.

DRUG

Chloroquine 600mg (Part 2 )

600mg Chloroquine given to each subject on Day 1 and Day2 of the trial.

DRUG

Chloroquine 300mg (Part 2 )

300mg Chloroquine given to each subject on Day 3 of the trial.

DRUG

Tafenoquine 300mg (Part 2)

single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2.

DRUG

Primaquine 15mg (Part2 )

15mg Primaquine given once daily to subject on treatment arm 3 on Days 2 to 15.

Trial Locations (14)

5306

GSK Investigational Site, Rio Tuba, Bataraza

10400

GSK Investigational Site, Bangkok

63110

GSK Investigational Site, Tak

226003

GSK Investigational Site, Lucknow

600016

GSK Investigational Site, Chennai

Unknown

GSK Investigational Site, Bāndarban

GSK Investigational Site, Oddar Meancheay Province

GSK Investigational Site, Gonder

GSK Investigational Site, Jimma

GSK Investigational Site, Bikaner

69040-000

GSK Investigational Site, Manaus

76812-329

GSK Investigational Site, Porto Velho

500 003

GSK Investigational Site, Secunderabad

Iqui 01

GSK Investigational Site, Iquitos

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Medicines for Malaria Venture

OTHER

lead

GlaxoSmithKline

INDUSTRY

NCT01376167 - Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse | Biotech Hunter | Biotech Hunter