A Phase 3, Double-Blind, Randomized Study of Arterolane Maleate-Piperaquine Phosphate vs Artemether-Lumefantrine for Falciparum Malaria in Adolescent and Adult Patients in Asia and Africa.

Abstract

BACKGROUND Artemisinins, which are derived from plants, are subject to risk of supply interruption due to climatic changes. Consequently, an effort to identify a new synthetic antimalarial was initiated. A fixed-dose combination of arterolane maleate (AM), a new synthetic trioxolane, with piperaquine phosphate (PQP), a long half-life bisquinoline, was evaluated in patients with uncomplicatedPlasmodium falciparummalaria. METHODS In this multicenter, randomized, double-blind, comparative, parallel-group trial, 1072 patients aged 12-65 years withP. falciparummonoinfection received either AM-PQP (714 patients) once daily or artemether-lumefantrine (A-L; 358 patients) twice daily for 3 days. All patients were followed up until day 42. RESULTS Of the 714 patients in the AM-PQP group, 638 (89.4%) completed the study; of the 358 patients in the A-L group, 301(84.1%) completed the study. In both groups, the polymerase chain reaction corrected adequate clinical and parasitological response (PCR-corrected ACPR) on day 28 in intent-to-treat (ITT) and per-protocol (PP) populations was 92.86% and 92.46% and 99.25% and 99.07%, respectively. The corresponding figures on day 42 in the ITT and PP populations were 90.48% and 91.34%, respectively. After adjusting for survival ITT, the PCR-corrected ACPR on day 42 was >98% in both groups. The overall incidence of adverse events was comparable. CONCLUSIONS AM-PQP showed comparable efficacy and safety to A-L in the treatment of uncomplicatedP. falciparummalaria in adolescent and adult patients. AM-PQP demonstrated high clinical and parasitological response rates as well as rapid parasite clearance. CLINICAL TRIALS REGISTRATION India. CTRI/2009/091/000101.

DOI: 10.1093/cid/ciw029

Cite this paper

@article{Toure2016AP3, title={A Phase 3, Double-Blind, Randomized Study of Arterolane Maleate-Piperaquine Phosphate vs Artemether-Lumefantrine for Falciparum Malaria in Adolescent and Adult Patients in Asia and Africa.}, author={Offianan Andre Toure and Neena Valecha and Antoinette Kitoto Tshefu and Ricardo Thompson and Srivicha Krudsood and Oumar Gaye and Bappanaidu Hoigegudde Krishnamurthy Rao and Issaka Sagara and Tarit Kumar Bose and Sanjib P Mohanty and Ballamudi Srinivas Rao and Anupkumar R. Anvikar and Victor Mwapasa and Harald Noedl and Sudershan Arora and Arjun Roy and Sunil S. Iyer and Pradeep Sharma and Nilanjan Saha and Rajinder K. Jalali and Landry Tiacoh and Sonia M Enosse and Noppadon Tangpukdee and Jack HT Kokolomami and Jean Louis A Ndiaye and D. Radha Rao and Ntamabyaliro Nsengi Yumva and Bouran Sidib{\'e} and Rajesh Mohanty and Amit Chandra Jha and Mulinda Nyirenda and Peter Starzengruber and Paul Swoboda}, journal={Clinical infectious diseases : an official publication of the Infectious Diseases Society of America}, year={2016}, volume={62 8}, pages={964-971} }