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Arterolane, a New Synthetic Trioxolane for Treatment of Uncomplicated Plasmodium falciparum Malaria: A Phase II, Multicenter, Randomized, Dose-Finding Clinical Trial
Neena Valecha, Sornchai Looareesuwan, Andreas Martensson, Salim Mohammed Abdulla, Srivicha Krudsood, Noppadon Tangpukdee, Sanjib Mohanty, Saroj K. Mishra, P. K. Tyagi, S. K. Sharma, Joerg Moehrle, Anirudh Gautam, Arjun Roy, Jyoti K. Paliwal, Monica Kothari, Nilanjan Saha, Aditya P. Dash and Anders Björkman
Clinical Infectious Diseases
Vol. 51, No. 6 (15 September 2010), pp. 684-691
Published by: Oxford University Press
Stable URL: http://www.jstor.org/stable/25742234
Page Count: 8
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Background. Drug-resistant Plasmodium falciparum malaria necessitates development of novel drugs for treatment. The present study assessed the efficacy and safety of 3 dose levels of arterolane (RBx 11160), a synthetic trioxolane, for treatment of acute uncomplicated falciparum malaria. Methods. In this randomized, double-blind, multicenter, parallel-group, dose-finding, phase II trial, 230 patients from 4 centers in Thailand, India, and Tanzania (mainland and Zanzibar) received either 50 mg (n = 78), 100 mg (n = 76), or 200 mg (n = 76) of arterolane once daily for 7 days. Patients (aged 13–65 years) with asexual parasite density of 1000–100,000 parasites/μL were included and were followed up for 28 days. The median time to 90% parasite clearance (PC₉₀) was evaluated. Results. The median PC₉₀ was longer in the group receiving the 50-mg dose (19.4 h), compared with the groups receiving the 100-mg dose (12.8 h) and 200-mg dose (12.6 h) (P<.01). The polymerase chain reaction—corrected adequate clinical and parasitological responses on day 28 were 63%, 71%, and 72% for the groups receiving the 50-mg, 100-mg, and 200-mg doses, respectively, by intention-to-treat analysis (odds ratio, 1.55; 95% confidence interval, 0.78–3.06, for comparison of the 200-mg and 50-mg dose groups). Treatment was generally well tolerated. No patient died or experienced any serious adverse event. Mild complaints were reported in <10% of the patients and were similar in the 3 groups. Biochemistry and hematological analyses did not show any sign of drug toxicity in any patient. Conclusion. Arterolane at daily doses of 100 and 200 mg is a rapidly acting, effective, and safe synthetic antimalarial drug, which may potentially represent an alternative to artemisinin derivatives in antimalarial combination therapy. Trial registration. ClinicalTrials.gov identifier NCT00362050.
Clinical Infectious Diseases © 2010 Oxford University Press