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

NCT06666491 | Recruiting Phase 3 DMC

• 1 other identifier: 208550
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Malaria, Vivax

Outcome Measures

Primary Outcomes (1)

• Number of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit

  Two consecutive negative blood smears between Day 2 and Day 8, no positive blood smear for P. vivax parasites at any point during the 6-month follow-up period, and a negative P. vivax smear at the 6-month assessment.

  Up to Month 6

Secondary Outcomes (26)

• Number of participants with clinically relevant hemolysis change from baseline

  Up to Day 14

• Time to recurrence of P. vivax malaria

  Up to Month 6

• Number of participants with treatment emergent adverse events (TEAEs) up to Month 6

  Up to Month 6

• Number of participants with TEAEs meeting >= Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 criteria

  Up to Month 6

• Number of participants with drug related TEAEs

  Up to Month 6

Study Arms (2)

TQ/CQ

EXPERIMENTAL

Participants in this group receive a single dose of TQ on Day 1 or Day 2 and a single dose of CQ daily, on Days 1 to 3.

Drug: Tafenoquine; Drug: Chloroquine

PQ/CQ

ACTIVE COMPARATOR

Participants in this group receive a single dose of PQ daily from Day 1 or 2, up to Day 14 (or Day 15 if PQ started on Day 2) and a single dose of CQ daily, on Days 1 to 3.

Drug: Primaquine; Drug: Chloroquine

Interventions

Tafenoquine DRUG

A single dose of TQ will be administered orally on Day 1 or Day 2.

TQ/CQ

Primaquine DRUG

A single dose of PQ will be administered orally, daily, on Day 1 or 2 to Day 14 (or Day 15 if PQ started on Day 2).

PQ/CQ

Chloroquine DRUG

A single dose of CQ will be administered orally, daily, on Days 1 to 3.

PQ/CQ; TQ/CQ

Eligibility Criteria

• Age: 2 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females \>=2 years of age and under (\<) 65 years of age, weighing \>10 kg.
• The participant has a positive malarial smear for P. vivax with a parasite density of \>100/microliter and \<100,000/microliter.
• The participant has a screening Hb value \>8 g/dL.
• The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
• 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).
• 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
• 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.
• 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.

You may not qualify if:

• The participant has severe P. vivax malaria as defined by WHO criteria \[WHO, 2023\].
• The participant has a mixed malaria infection (identified by a malarial smear).
• 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).
• The participant has a history of porphyria, psoriasis, or epilepsy.
• 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.
• The participant has received treatment with any investigational drug within 30 days of study entry, or within 5 half-lives, whichever is longer.
• The participant has previously enrolled in this study.
• 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.
• Participants with a current or past history of serious psychiatric disorders.
• 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.
• The participant is known to be HIV-infected and/or is currently on antiretroviral therapy.
• The participant is regularly using drugs with hemolytic potential.
• The participant has a QT corrected by Fridericia's formula (QTcF) \>450 msec, evidence of bradycardia (\<50 beats per min) or ventricular arrhythmias on the screening ECG, a history of cardiac disease (e.g., myocardial infarction, congenital heart disease, or arrhythmia), hypokalemia (\<2.9 millimoles per liter \[mmol/L\]) or hyperkalemia (\>=6.0 mmol/L) at Screening.
• The participant has taken drugs with antimalarial activity (e.g., artemisinin-based combination therapies, mefloquine, primaquine, chloroquine, tafenoquine or any other 4-AQ) within 30 days prior to study entry.
• The participant has taken or will likely require during the study the use of:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Ahmedabad, 380008, India

RECRUITING

GSK Investigational Site

Kolkata, 700073, India

RECRUITING

GSK Investigational Site

Mumbai, 400012, India

RECRUITING

GSK Investigational Site

Surat, 395004, India

RECRUITING

MeSH Terms

Conditions

Malaria, Vivax

Interventions

tafenoquine; Primaquine; Chloroquine

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

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 30, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

IN (4)