Vivax Malaria Clinical Trial
Official title:
Randomised Parallel Open Label Comparison Between 7 and 14 Day Primaquine Combined With 3-day Dihydroartemisinin-piperaquine or 3-day Chloroquine Regimens for Radical Cure of Plasmodium Vivax
In Southeast Asia, Plasmodium vivax (Pv) infection reaches 50-80% and bears a greater burden
of disease than Plasmodium falciparum (Pf). As control over Pf improves, Pv will assume
increasingly larger percentages of malaria prevalence. The chronicity of Pv, due to the
latent liver stage (hypnozoite) not eradicated by chloroquine, causes recurring disability
and compounds the economic burden of those with symptomatic disease. The only widely
available treatment for hypnozoites is primaquine, which, because of challenges with
tolerability, safety in G6PD deficient persons, and compliance, is not commonly prescribed
for the treatment of Pv. Currently, chloroquine is used for the treatment of the blood
stages of Pv, however, there are concerns about increasing parasite resistance. Alternative
treatments, such as artesunate, should be considered in the future of the treatment of blood
stage Pv. The use of primaquine in the treatment of hypnozoites (radical cure) should be
emphasized so that transmission of Pv can be controlled.
This study aims to determine the optimal primaquine regimen for radical cure of Plasmodium
vivax. Chloroquine is currently the standard of treatment for Plasmodium vivax. Chloroquine
may have synergistic effects when used with primaquine and due to its long half-life may
delay the first relapse of vivax malaria. In contrast, artesunate does not have documented
interactions with primaquine and has a very short half-life, thus, presumably will have no
impact on first relapse. Combining primaquine with these two anti-malarials may lead to an
alternative regimen for Pv infection and changing the primaquine dosing regimen may lead to
a more practical and efficacious therapy.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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