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Clinical Trial
. 2010 Feb;54(2):792-8.
doi: 10.1128/AAC.00354-09. Epub 2009 Dec 7.

Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects

Peter E Nasveld  1 , Michael D Edstein, Mark Reid, Leonard Brennan, Ivor E Harris, Scott J Kitchener, Peter A Leggat, Philip Pickford, Caron Kerr, Colin Ohrt, William Prescott; Tafenoquine Study Team
Collaborators, Affiliations
Clinical Trial

Randomized, double-blind study of the safety, tolerability, and efficacy of tafenoquine versus mefloquine for malaria prophylaxis in nonimmune subjects

Peter E Nasveld et al. Antimicrob Agents Chemother. 2010 Feb.

Abstract

This study represents the first phase III trial of the safety, tolerability, and effectiveness of tafenoquine for malaria prophylaxis. In a randomized (3:1), double-blinded study, Australian soldiers received weekly malaria prophylaxis with 200 mg tafenoquine (492 subjects) or 250 mg mefloquine (162 subjects) for 6 months on a peacekeeping deployment to East Timor. After returning to Australia, tafenoquine-receiving subjects received a placebo and mefloquine-receiving subjects received 30 mg primaquine daily for 14 days. There were no clinically significant differences between hematological and biochemical parameters of the treatment groups. Treatment-related adverse events for the two groups were similar (tafenoquine, 13.4%; mefloquine, 11.7%). Three subjects on tafenoquine (0.6%) and none on mefloquine discontinued prophylaxis because of possible drug-related adverse events. No diagnoses of malaria occurred for either group during deployment, but 4 cases (0.9%) and 1 case (0.7%) of Plasmodium vivax infection occurred among the tafenoquine and mefloquine groups, respectively, up to 20 weeks after discontinuation of medication. In a subset of subjects recruited for detailed safety assessments, treatment-related mild vortex keratopathy was detected in 93% (69 of 74) of tafenoquine subjects but none of the 21 mefloquine subjects. The vortex keratopathy was not associated with any effect on visual acuity and was fully resolved in all subjects by 1 year. Tafenoquine appears to be safe and well tolerated as malaria prophylaxis. Although the volunteers' precise exposure to malaria could not be proven in this study, tafenoquine appears to be a highly efficacious drug for malaria prophylaxis.

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Figures

FIG. 1.
FIG. 1.
Drug administration and safety analysis schedule for tafenoquine and mefloquine. metHb, methemoglobin.
FIG. 2.
FIG. 2.
Flow diagram of subject accountability during the study.
See this image and copyright information in PMC

References

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