Actively Recruiting
A Randomized, Open-label, Multi-center, Phase 3 Study Comparing Tafenoquine and Primaquine with Chloroquine for Treating Plasmodium Vivax Malaria in Indian Participants Aged 2 to 64 Years
Led by GlaxoSmithKline · Updated on 2025-08-07
300
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two drugs, tafenoquine and primaquine, each taken with chloroquine, for treating Plasmodium vivax malaria in Indian participants aged 2 years and older. This study aims to gather data to support the approval of tafenoquine in India. It is a randomized, open-label, multi-center, phase 3 interventional trial sponsored by GlaxoSmithKline. Participants are randomly assigned to one of two groups. One group receives a single dose of tafenoquine on Day 1 or Day 2 alongside daily doses of chloroquine for three days. The other group receives daily doses of primaquine from Day 1 or 2 up to Day 14 or 15, also combined with chloroquine daily for three days. The trial monitors the effects of these treatments over time, focusing on preventing relapse of malaria. During the study, participants undergo regular assessments including blood smears, clinical chemistry tests, hematology evaluations, and monitoring for adverse events up to six months post-treatment. The main outcome measured is the number of participants who remain free from malaria recurrence six months after treatment. Safety is closely monitored through laboratory tests and reporting of any side effects. Participation lasts up to six months, with multiple scheduled visits for evaluation and follow-up.
CONDITIONS
Brief 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...
- Male or female aged 2 years or older and under 65 years, weighing over 10 kg
- Confirmed positive blood smear for P. vivax malaria with parasite density between 100 and 100,000 per microliter
- Screening hemoglobin (Hb) value greater than 8 g/dL
- Axillary temperature of 37.56C or history of fever within 48 hours before recruitment
- G6PD enzyme activity value of at least 6.1 units/gram Hb as measured by SD Biosensor STANDARD G6PD test
- Female participants must not be pregnant or breastfeeding
- Women of childbearing potential must use a highly effective contraceptive method during the study and for at least 90 days after last dose
- Women of childbearing potential must have a negative pregnancy test before first dose
- Willing and able to comply with study procedures and provide written informed consent (and assent if applicable)
You will not qualify if you...
- Severe P. vivax malaria as defined by WHO criteria
- Mixed malaria infection confirmed by blood smear
- Conditions affecting medication absorption, such as severe vomiting within 8 hours prior
- History of porphyria, psoriasis, or epilepsy
- Allergy or intolerance to mefloquine, chloroquine, tafenoquine, primaquine, or related drugs
- Treatment with any investigational drug within 30 days or 5 half-lives prior to study entry
- Previous enrollment in this study
- Recent illicit drug abuse or heavy alcohol use affecting participation
- Current or past serious psychiatric disorders
- Significant concurrent illnesses or pre-existing conditions like pneumonia, tuberculosis, meningitis, severe malnutrition, or autoimmune diseases
- HIV infection or current antiretroviral therapy
- Regular use of drugs with hemolytic potential
- Abnormal cardiac conditions including prolonged QTc, bradycardia, arrhythmias, or history of cardiac disease
- Use of antimalarial drugs within 30 days prior to study
- Use or likely need for certain medications during study, including histamine-2 blockers, antacids (first 3 days), biguanides, anti-arrhythmic agents, and QTc-prolonging drugs
- Liver enzymes (ALT/AST) more than twice the upper normal limit at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days
Participants receive either a single dose of Tafenoquine or daily doses of Primaquine for up to 14 or 15 days, combined with daily Chloroquine for 3 days.
Daily visits for up to 15 days
Duration - Up to 6 months
Participants are monitored for safety and efficacy outcomes including recurrence of malaria and adverse events.
Multiple follow-up visits up to 6 months
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
E
EU GSK Clinical Trials Call Center
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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