Loading clinical trials...

An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older | Clinical Trials | Clareo Health

RECRUITINGPHASE3

An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older

A Randomized, Open-label, Multi-center, Interventional Phase 3 Study of the Efficacy and. Safety of Tafenoquine Compared to Primaquine (Both Co-administered With Chloroquine) for the Radical Cure (Relapse Prevention) of Plasmodium Vivax (P. Vivax) Malaria in Indian Participants (Pediatric and Adult Population)

NCT06666491•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.

Eligibility

Age

2 - 64 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females \>=2 years of age and under (\<) 65 years of age, weighing \>10 kg.
•2. The participant has a positive malarial smear for P. vivax with a parasite density of \>100/microliter and \<100,000/microliter.
•3. The participant has a screening Hb value \>8 g/dL.
•4. The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
•5. The participant has a G6PD value (measured using the SD Biosensor STANDARDTM G6PD test) 6.1 units/gram (U/g) Hb for G6PD activity (6.1 U/g Hb cut-off is applicable for both males and females).
•6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and if one of the following conditions applies:
•* Is a woman of non-childbearing potential (WONCBP) as defined in
•* Is a Women of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, during the study intervention period and for at least 90 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
•7. A WOCBP must test negative on a highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.
•8. The participant is willing and able to comply with the procedures described in the study protocol. The participant or parent/legal guardian, as applicable, has given written informed, dated consent; and the participant has given written assent, if applicable, to participate in the study.

Exclusion Criteria

•1. The participant has severe P. vivax malaria as defined by WHO criteria \[WHO, 2023\].
•2. The participant has a mixed malaria infection (identified by a malarial smear).
•3. The participant has a condition that may affect absorption of study medication, such as severe vomiting (no food or inability to take food during the previous 8 hours).
•4. The participant has a history of porphyria, psoriasis, or epilepsy.
•5. The participant has a history of allergy, intolerance to or a known contraindication to the use of mefloquine (or other aryl amino alcohol drugs), chloroquine, tafenoquine, primaquine, any other 4- or 8-AQ or any of their respective excipients.
•6. The participant has received treatment with any investigational drug within 30 days of study entry, or within 5 half-lives, whichever is longer.
•7. The participant has previously enrolled in this study.
•8. The participant has a recent history of illicit drug abuse or heavy alcohol intake that in the opinion of the investigator could compromise full participation in the study or adherence to study procedures.
•9. Participants with a current or past history of serious psychiatric disorders.
•10. The participant has a clinically significant concurrent illness (e.g., pneumonia, tuberculosis, meningitis, septicemia, dengue, coagulopathy, severe hemorrhage, or febrile convulsions prior to consent) or a pre-existing condition (e.g., renal disease, malignancy, or severe malnutrition according to WHO child growth standards) or systemic disease predisposing patients to suffer from granulocytopenia, such as rheumatoid arthritis and lupus erythematosus or severe ocular disease.
+11 more criteria

Locations (4)

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Kolkata, India

GSK Investigational Site

Mumbai, India

GSK Investigational Site

Surat, India

Key Dates

Start Date

November 13, 2024

Primary Completion Date

May 25, 2026

Completion Date

May 25, 2026

Last Updated

August 7, 2025

Enrollment

300

ESTIMATED participants

Conditions

Malaria, Vivax

Interventions

Tafenoquine

DRUG

Primaquine

DRUG

Chloroquine

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua

NCT06036030

Malaria,FalciparumMalaria, Vivax+4 more

View study

COMPLETEDNA

Study of Controlled Human Plasmodium Vivax Infection

NCT03377296

Malaria, Vivax

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older

Inclusion Criteria

Exclusion Criteria

Combination Momordica Charantia Extract and Primaquine Againts Plasmodium Falciparum Uncomplicated and Plasmodium Vivax Uncomplicated Treatment in Manokwari, West Papua

Study of Controlled Human Plasmodium Vivax Infection

Primaquine Double Dose for Radical Cure of Plasmodium Vivax in Colombia

Efficacy of 3 Regimens of Chloroquine and Primaquine for Treatment of P. Vivax Malaria, Cruzeiro do Sul, Acre, Brazil

A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria

Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria