At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-centre, Double-blind, Randomised, Parallel-group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tafenoquine (SB-252263, WR238605) in Subjects With Plasmodium Vivax Malaria.
In Brief
A Phase 2 clinical trial evaluating Chloroquine 600mg, Chloroquine 300mg, and 9 other interventions for Malaria, Vivax. Completed, enrolled 851 participants across 14 sites in 8 countries.
Detailed Summary
The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the control Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax Malaria.
Study Details
Timeline
Interventions
600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
300mg Chloroquine given to each subject on Day 3 of the trial
single dose 50mg Tafenoquine given to subject on treatment arm 1 on Days 1 or 2
single dose 100mg Tafenoquine given to subject on treatment arm 2 on Days 1 or 2
single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2
single dose 600mg Tafenoquine given to subject on treatment arm 4 on Days 1 or 2
15mg Primaquine given once daily to subject on treatment arm 5 on Days 2 to 15.
600mg Chloroquine given to each subject on Day 1 and Day2 of the trial.
300mg Chloroquine given to each subject on Day 3 of the trial.
single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2.
15mg Primaquine given once daily to subject on treatment arm 3 on Days 2 to 15.