Tafenoquine Combinations for Improved Radical Cure Efficacy of Plasmodium Vivax

NCT07533136 | Not Yet Recruiting DMC

• 2 other identifiers: WRAIR#3297CDMRPL-24-0-PR241374
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uncomplicated P. Vivax Mono-infection

Keywords

Plasmodium vivax, Tafenoquine, Artemisinin combination therapy

Outcome Measures

Primary Outcomes (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

  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.

  From enrollment to 6 months follow up

Study Arms (4)

TQ+CQ Arm

ACTIVE COMPARATOR

TQ 300 mg once + Chloroquine (CQ), weight-based dosing for 3 days course

Drug: Tafenoquine (TQ); Drug: Chloroquine (CQ)

TQ+DHA-PPQ Arm

ACTIVE COMPARATOR

TQ 300 mg once + Dihydroartemisinin-piperaquine (DHA-PPQ), weight-based dosing for 3 days course

Drug: Tafenoquine (TQ); Drug: Dihydroartemisinin-piperaquine (DHA-PPQ)

TQ+AL Arm

ACTIVE COMPARATOR

TQ 300 mg once + Artemether-Lumefantrine (AL), weight-based dosing twice daily for the 3-day course

Drug: Tafenoquine (TQ); Drug: Artemether-lumefantrine (AL)

DHA-PPQ + delayed TQ Arm

ACTIVE COMPARATOR

DHA-PPQ weight-based dosing for the 3-day course, then pause the treatment for one day and tafenoquine 300 mg once on the 4th day.

Drug: Tafenoquine (TQ); Drug: Dihydroartemisinin-piperaquine (DHA-PPQ)

Interventions

Tafenoquine (TQ) DRUG

Tafenoquine 150 mg

Also known as: KRINTAFEL

DHA-PPQ + delayed TQ Arm; TQ+AL Arm; TQ+CQ Arm; TQ+DHA-PPQ Arm

Chloroquine (CQ) DRUG

Chloroquine 150 mg base

TQ+CQ Arm

Dihydroartemisinin-piperaquine (DHA-PPQ) DRUG

It is 40 mg DHA/320 mg PPQ

Also known as: Eurartesim

DHA-PPQ + delayed TQ Arm; TQ+DHA-PPQ Arm

Artemether-lumefantrine (AL) DRUG

It is 20 mg of artemether and 120 mg lumefantrine

Also known as: Coartem

TQ+AL Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Walter Reed Army Institute of Research (WRAIR): lead

Study Sites (1)

Tha Song Yang Hospital

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Malaria, Vivax

Interventions

tafenoquine; Chloroquine; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Brian Vesely, PhD

  Walter Reed Army Institute of Research-Armed Forces Research Institute of Medical Sciences (WRAIR-AFRIMS), Thailand

  STUDY CHAIR

Central Study Contacts

Dr. Krisada Jongsakul, MD

CONTACT

+66 2 696 2700; krisadaj.ca@afrims.org

Sidhartha Chaudhury, PhD

CONTACT

+66-2-696-2700; sidhartha.chaudhury.mil@afrims.org,

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a four arm, randomized and open label and clinical efficacy trial.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): May 30, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)