Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
This is a single-centre, controlled, open label study using P. falciparum-induced blood stage
malaria (IBSM) infection to assess the effectiveness of OZ439 as a gametocytocidal agent, as
well as its treatment effects on gametocyte infectivity and development in vector mosquitoes.
Previous clinical studies including one IBSM study have shown that in addition to effectively
clearing replicating, asexual (pathogenic) life cycle stages of malaria, a single dose of
piperaquine (480 mg) results in the production of gametocytes, as determined by
gametocyte-specific transcript (pfs25) qPCR. The propensity of piperaquine to induce
gametocytaemia will be employed in this study to assess the efficacy of OZ439 as a
gametocytocidal and transmission blocking agent. Experimental mosquito feeding via both
direct feeding on participants and artificial (indirect) membrane mosquito feeding will be
performed. The study will be conducted in up to 3 cohorts where participants will be
randomised into an experimental or a control group (n=2 per group) when peak gametocytemia
occurs (approximately 15 days after administration of piperaquine).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Medicines for Malaria Venture
Collaborators:
Army Malaria Institute, Australia Clinical Network Services (CNS) Pty Ltd Q-Pharm Pty Limited QIMR Berghofer Medical Research Institute Sullivan Nicolaides Pathology