Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax
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
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
Treatments tested in this trial
- Tafenoquine (TQ)
- Chloroquine (CQ)
- Dihydroartemisinin-piperaquine (DHA-PPQ)
- Artemether-lumefantrine (AL)
Treatment groups
300 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov