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

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.

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.

Sponsors & Collaborators

• Medicines for Malaria Venture

  collaborator OTHER

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-24

Primary Completion

2016-11-18

Completion

2016-11-18

Countries

• Bangladesh
• Brazil
• Cambodia
• Ethiopia
• India
• Peru
• Philippines
• Thailand

Study Locations