A study to compare the efficacy and safety of tafenoquine and primaquine when either are taken together with chloroquine for the treatment of P. vivax malaria in Indian participants aged 2 years and older
- Conditions
- Health Condition 1: B51- Plasmodium vivax malaria
- Registration Number
- CTRI/2024/07/071492
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Males and females greater than or equal to 2 years of age and less than 65 years of age, weighing more than 10 kg.
2.The participant has a positive malarial smear for P. vivax with a parasite density of greater than 100 per microliter and less than 100,000 per microliter
3.The participant has a screening Hb value greater than 8 g per dL.
4.The participant has an axillary temperature greater than or equal to 37.5?deg C or history of fever 48 hours before recruitment.
5.The participant has a G6PD value (measured using the SD Biosensor STANDARD G6PD test) greater than 6.1 U per g Hb for G6PD activity.
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 Section
Or
-Is a Women of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective with low user dependency during the study intervention period and for at least 90 days after the last dose of study intervention..
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.
1.The participant has severe P. vivax malaria as defined by WHO criteria 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.The participant is known to be HIV-infected and or is currently on antiretroviral therapy.
12.The participant is regularly using drugs with hemolytic potential.
13.The participant has a QT corrected by Fridericia’s formula (QTcF) greater than 450 msec evidence of bradycardia (less than 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 (less than 2.9 mmol per L) or hyperkalemia (greater than or equal to 6.0 mmol per L) at Screening.
14.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
15.The participant has taken or will likely require during the study the use of:
a.Histamine-2 blockers (restricted to first 3 days whilst receiving CQ)
b.Antacids (restricted to first 3 days whilst receiving CQ)
c.Anti-diabetic drugs of the biguanide class (i.e., phenformin, metformin, buformin)
d.Anti-arrhythmic agents (i.e., dofetilide, procainamide, pilsicainide)
e.Medications that prolong the QTc interval
16.The participant has liver transaminases (ALT, AST) greater than 2 times the upper limit of normal (ULN).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method