Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax (NCT07533136) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax
Thailand300 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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; speci…
What they're measuring
1
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
Timeframe: From enrollment to 6 months follow up
Trial details
NCT IDNCT07533136
SponsorWalter Reed Army Institute of Research (WRAIR)