Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults

PHASE2TerminatedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

September 15, 2003

Primary Completion Date

January 10, 2005

Study Completion Date

January 10, 2005

Conditions
MalariaPlasmodium Vivax
Interventions
DRUG

Tafenoquine

Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.

DRUG

Chloroquine + Primaquine

Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.

DRUG

tafenoquine

Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.

DRUG

Chloroquine + Primaquine

Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.

Trial Locations (1)

10400

Bangkok Hospital for Tropical Diseases/Mahidol University, Bangkok

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

U.S. Army Medical Research and Development Command

FED