Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax

Starting soon · Not applicable

Conditions studied: Uncomplicated P. Vivax Mono-infection

In brief

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.

Key facts

Study ID: NCT07533136
Run by: Walter Reed Army Institute of Research (WRAIR)
People needed: 300
Starts: 2026-05-01
Expected to finish: 2029-05-30
Last updated by the study team: 2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants who meet all of the following criteria may participate in the study:
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
Agree to not seek outside medical care prior to contacting the WRAIR-AFRIMS study team if a fever develops during study participation (approximately 180 days), unless emergency medical care is required

You may not qualify if…

Participants meeting any of the following criteria will be excluded from this study:
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
Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, neurologic, or renal functional abnormality, as determined by history, physical examination, and laboratory evaluation; specific tests for this criteria, and in the definition of severe malaria, include:
Hemoglobin level of <7 g/dL
Alanine aminotransferase (ALT/SGPT) and/or Aspartate transaminase (AST/SGOT) more than two times upper limit of normal or total bilirubin greater than 3 mg/dL
Serum creatinine greater than 3 mg/dL
History of or current psychotic disorders (schizophrenia or other type of psychosis with hallucinations/delusions)
Have symptoms of severe malaria needing urgent treatment, such as impaired consciousness, shock, seizures, respiratory distress, unable to eat or drink, prostration (WHO guidelines for malaria, 2024) or other signs/symptoms of concern to the doctors
Are a pregnant or lactating female, or female of childbearing age, up to 50 years of age or otherwise individually assessed for childbearing potential, who does not agree to use an acceptable form of contraception (e.g. pills or injectable) during this study and for 1 month after study completion
Chronic use of medications that may cause drug interactions with tafenoquine (metformin) and/or drugs known to prolong the QTc interval.
Any other significant finding that in the opinion of the study physician would increase the risk of having an adverse outcome from participating in this study

Where it is running

Tha Song Yang Hospital — Ratchathewi, Bangkok, Thailand

Full record on ClinicalTrials.gov

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