Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax

ConditionUncomplicated P. Vivax Mono-infection

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorWalter Reed Army Institute of Research (WRAIR)

About this trial

This study is to conduct a clinical trial of tafenoquine combinations to compare the rates of therapeutic efficacy of dihydroartemisinin-piperaquine or artemether-lumefantrine with tafenoquine to chloroquine plus tafenoquine in preventing recurrence of Plasmodium vivax over a 6-month period in adult subjects with uncomplicated P. vivax infection living in Thailand.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Thai or non-Thai, male or non-pregnant/non-lactating female, aged at least 18 years

Willingness to participate in the study and provides signed written informed consent form

Have P. vivax malaria mono-infection as determined by blood smear, with a parasitemia range of 100-400,000 parasites/microliter

Have normal (non-deficient or >70% activity) G6PD phenotype as measured by quantitative spectrophotometry

Disqualifiers

Have an allergic reaction to any of the study drugs or components (AL,TQ, artemisinins, PPQ or CQ)

History of anti-malarial drug use within the past 14 days (28 days for mefloquine or PPQ)

On screening EKG, found to have a QTcF of greater than 450 milliseconds (ms) (470 ms for females)

History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias

Trial design

Design model

Parallel

Treatments tested in this trial

Tafenoquine (TQ)
Drug
Tafenoquine 150 mg
Chloroquine (CQ)
Drug
Chloroquine 150 mg base
Dihydroartemisinin-piperaquine (DHA-PPQ)
Drug
It is 40 mg DHA/320 mg PPQ
Artemether-lumefantrine (AL)
Drug
It is 20 mg of artemether and 120 mg lumefantrine

Treatment groups

300 Participants

are divided into 4 treatment groups

Group A: TQ+CQ ArmActive comparator 2 interventions

Group B: TQ+DHA-PPQ ArmActive comparator 2 interventions

Group C: TQ+AL ArmActive comparator 2 interventions

Group D: DHA-PPQ + delayed TQ ArmActive comparator 2 interventions

Trial outcomes

Primary outcomes

Estimate the rate of recurrence in all participants with uncomplicated P. vivax mono-infection in the 6 months following treatment with chloroquine, CQ, artemether-lumefantrine, AL, or dihydroartemisinin-piperaquine, DHA-PPQ, paired with tafenoquine, TQ

After discharge from hospital, outpatient follow-up visits will be scheduled at Day 14, 18 (Arm 4), 21, 25 (Arm 4), 28, 32 (Arm 4), 60, 90, 120, 150 and 180 to monitor for P. vivax recurrences.

Time frame

From enrollment to 6 months follow up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Walter Reed Army Institute of Research (WRAIR)

Lead sponsor

Source ClinicalTrials.gov

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