The goal of this Phase 2b study is to examine the safety and efficacy of the combination of SJ733, an investigational agent, and tafenoquine for the radical cure of uncomplicated P. vivax malaria monoinfection in adult participants and determine the contributions of SJ733 to the effect. SJ733 will be administered in a 1-, 2-, or 3-day treatment schedule in combination with a single dose of tafenoquine.
Body weight between 45 kg and 90 kg inclusive.
Presence of mono-infection of P. vivax confirmed by: Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and, Microscopically confirmed parasite infection: 1,000 to 40,000 asexual parasite count/µL blood
Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations.
Ability to swallow oral medication.
Signs and symptoms of severe/complicated malaria according to the World Health Organization Criteria 2010.
Mixed Plasmodium infection or Plasmodium mono-infection with any Plasmodium species other than P. vivax.
Severe vomiting, defined as more than three times in the 24 hours prior to the planned first dose of drug, or severe diarrhea defined as 3 or more watery stools per day.
Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalized reference values).
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Treatment groupsSee each treatment group below.
R. Kiplin Guy
Lead sponsor
University of Kentucky
Sponsor institution
Global Health Innovative Technology Fund
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
University of Minnesota
Collaborator