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RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MALARONE FOR MALARIA PROPHYLAXIS IN NON-IMMUNE COLOMBIAN SOLDIERS

Malarone was compared with placebo in a double-blind, randomized, placebo-controlled trial of prophylaxis of malaria in predominately Plasmodium vivax areas of Colombia. The study population consisted of 180 completely non-immune Colombian soldiers, male, average age 19 years, and average weight 63 kg. Twenty-four subjects were considered unevaluable because of compliance issues, including one Malarone subject (with no detectable drug levels) who became infected with P. vivax. Of the 97 evaluable subjects who received Malarone (250 mg atovaquone plus 100 mg proguanil hydrochloride) daily from 1 day before entering the endemic area to 7 days after leaving the endemic area, none became parasitemic. Of the 46 evaluable placebo subjects, 11 became infected with P. vivax and 2 became infected with Plasmodium falciparum. The protective efficacy of Malarone for all malaria and for P. vivax malaria was 100% (LL 95% CI = 63%) and 100% (LL 95% CI = 58%), respectively, and was 96% if the one case with undetectable blood levels was included. Malarone has high protective efficacy for P. vivax in Colombia.

Received February 13, 2006. Accepted for publication April 13, 2006.

Acknowledgment: The authors thank the efforts and participation of the commanders and soldiers from Brigada XIV in Uraba and Batallón 21 Vargas in Granada.

Disclosure: Stephane Duparc is an employee of GlaxoSmithKline and is identified as such on the authorship page. This statement is made in the interest of full disclosure and not because the author considers this to be a conflict of interest.

Financial support: This study was supported by a grant from Glaxo Smith Kline to Dr. Soto.

^* Address correspondence to J. Berman, 6205 Poindexter Lane, North Bethesda, MD 20852. E-mail: JBe9320457{at}aol.com

Authors’ addresses: Jaime Soto, Julia Toledo, and Magda Luzz, Consorcio de Investigaciones Bioclinicas, Calle 60 A 5-54, Suite 201, Bogota, Colombia, Telephone: 57-1-348-2171, Fax: 57-1-347-6093, E-mail: Jaime.Soto{at}cable.net.co. Patricia Gutierrez, Fundacion Fader, Bogota, Colombia. Jonathan Berman, 6205 Poindexter Lane, North Bethesda, MD. Stephane Duparc, GlaxoSmithKline, Research & Development, Greenford, UK.

Reprint requests: Jaime Soto, Consorcio de Investigaciones Bioclinicas, Calle 60 A 5-54, Suite 201, Bogota, Colombia, Telephone: 57-1-348-2171, Fax: 57-1-347-6093, E-mail: Jaime.Soto{at}cable.net.co.

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