A Phase 3 interventional study of Tafenoquine and Primaquine in Malaria, Vivax, sponsored by GlaxoSmithKline. Recruiting at 5 sites in India. Open to participants aged 2 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
103 studies on the registry are indexed under Malaria, Vivax; 17 are open to participants now.
This study's planned enrollment of 324 is above the median of 150 across 87 interventional studies indexed under Malaria, Vivax.
Browse Malaria, Vivax studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and if one of the following conditions applies:
Exclusion Criteria:
The participant has taken or will likely require during the study the use of:
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
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
A single dose of TQ will be administered orally on Day 1 or Day 2.
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).
A single dose of CQ will be administered orally, daily, on Days 1 to 3.
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.
Time frame: Up to Month 6
Number of participants with clinically relevant hemolysis change from baseline
A decrease in hemoglobin of greater than or equal to (\>=) 30% or greater than (\>) 3g/deciliter (dL) from baseline; or an overall drop in hemoglobin below 6.0 g/dL or complications thereof (e.g., required transfusions, acute renal failure) are considered clinically relevant hemolysis changes.
Time frame: Up to Day 14
Time to recurrence of P. vivax malaria
Recurrence is defined as a positive blood smear for P. vivax parasites within the 6-month follow-up period, after clearance of blood-stage parasitemia.
Time frame: Up to Month 6
Number of participants with treatment emergent adverse events (TEAEs) up to Month 6
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with TEAEs meeting >= Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 criteria
Severity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening, Grade 5-Death.
Time frame: Up to Month 6
Number of participants with drug related TEAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with serious AEs (SAEs)
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Time frame: Up to Month 6
Number of participants with AEs resulting in treatment discontinuation
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with AEs leading to study withdrawal
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of participants with AEs considered to be hematologically related
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Month 6
Number of deaths
Time frame: Up to Month 6
Liver chemistry changes meeting Hy's criteria
Hy's criteria cases were defined as any elevated alanine aminotransferase (ALT) \>=3 times upper limit of normal (ULN) and total bilirubin \>=2 times ULN or ALT \>=3 times ULN and international normalized ratio (INR) \>1.5.
Time frame: Up to Month 6
Laboratory parameters meeting >= Division of AIDS (DAIDs) Grade 3 criteria
Time frame: Up to Month 6
Vital sign parameters meeting >=DAIDs Grade 3 criteria
Time frame: Up to Month 6
Number of participants with TEAEs up to Week 4
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to Week 4
Change from baseline at each study visit for clinical chemistry parameters (ALT, AST, ALP)
Data for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) is measured in international units/liter (IU/L).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (CPK)
Data for creatine phosphokinase (CPK) is measured in units per liter (U/L).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (total bilirubin, indirect bilirubin, blood urea nitrogen [BUN]/Urea, and serum creatinine)
Clinical chemistry parameters are measured in milligrams per decilitre (mg/dL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (serum electrolytes)
Data for serum electrolytes is measured in millimoles per liter (mmol/L).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (platelet count)
Platelets are measured in number of platelets per microliter (µL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (red blood cell [RBC] count)
Data for RBC is measured in millions of cells per microliter (number of RBCs x10\^6/µL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular volume [MCV])
Data for MVC is measured in femtoliters (fL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular hemoglobin [MCH])
Data for MCH is measured in picograms (pg) per cell.
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (percentage of reticulocytes)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (white blood cell count [WBC] with differential)
Data for neutrophils, lymphocytes, monocytes, eosinophils and basophils is presented as a count, which measures a percentage (%) of the WBC.
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hemoglobin)
Hemoglobin is measured in grams per deciliter (g/dL).
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hematocrit)
Hematocrit is measured in volume percentage (%) of RBC in blood.
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Plan to share: Yes — GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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