Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2025-08-07
300
Participants Needed
4
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 2 to under 65 years, weighing more than 10 kg
- Positive malaria smear for P. vivax with parasite density between 100 and 100,000 per microliter
- Hemoglobin level greater than 8 g/dL
- Axillary temperature of 37.5°C or history of fever within 48 hours before recruitment
- G6PD activity of at least 6.1 units/gram hemoglobin measured by SD Biosensor STANDARDTM G6PD test
- Female participants must not be pregnant or breastfeeding
- Women of childbearing potential must use a highly effective contraceptive method during and for 90 days after the study
- Women of childbearing potential must have a negative pregnancy test before receiving study treatment
- Willing and able to comply with study procedures and provide informed consent or assent
You will not qualify if you...
- Severe P. vivax malaria as defined by WHO criteria
- Mixed malaria infection detected by smear
- Conditions affecting medication absorption, such as severe vomiting with inability to eat for 8 hours
- History of porphyria, psoriasis, or epilepsy
- Allergy or intolerance to mefloquine, chloroquine, tafenoquine, primaquine, or related drugs
- Use of investigational drugs within 30 days or 5 half-lives before study entry
- Previous enrollment in this study
- Recent history of illicit drug abuse or heavy alcohol intake affecting participation
- Current or past serious psychiatric disorders
- Significant concurrent illness or pre-existing conditions like pneumonia, tuberculosis, meningitis, septicemia, dengue, coagulopathy, severe hemorrhage, febrile convulsions, renal disease, malignancy, severe malnutrition, rheumatoid arthritis, lupus erythematosus, or severe eye disease
- Known HIV infection or current antiretroviral therapy
- Regular use of drugs with hemolytic potential
- QTcF greater than 450 msec, bradycardia below 50 bpm, ventricular arrhythmias, history of cardiac disease, or abnormal potassium levels at screening
- Antimalarial drug use within 30 days prior to study entry
- Use of certain drugs during the study including histamine-2 blockers or antacids during chloroquine treatment, biguanides, anti-arrhythmic agents, or medications prolonging QTc interval
- Liver enzymes (ALT/AST) more than twice the upper limit of normal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
GSK Investigational Site
Ahmedabad, India, 380008
Actively Recruiting
2
GSK Investigational Site
Kolkata, India, 700073
Actively Recruiting
3
GSK Investigational Site
Mumbai, India, 400012
Actively Recruiting
4
GSK Investigational Site
Surat, India, 395004
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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