Arterolane and Piperaquine Vs. Artemether and Lumefantrine in Uncomplicated Malaria: A Randomized Study in Nigeria.

Objective: To compare the efficacy and safety of Arterolane maleate-Piperaquine phosphate (AMP) and Artemether-lumefantrine (AL) in Nigerian patients with acute, uncomplicated Plasmodium falciparum malaria.

Methods: This phase IV, randomized, multicenter, open-label, active-controlled study included patients aged 12-65 years with acute symptomatic, uncomplicated P. falciparum malaria. A total of 350 patients were randomized (1:1) to Test group [AMP (150 mg+750 mg) once daily] or Comparator group [AL (80 mg+480 mg) twice daily] for 3 consecutive days. The primary endpoint was polymerase chain reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) on Day 28. Secondary endpoints included PCR-corrected ACPR (Day 42), PCR-uncorrected ACPR (Days 28 and 42), fever clearance time (FCT), and parasite clearance time (PCT).

Results: PCR-corrected ACPR was 100% on Day 28 and sustained till Day 42 in both groups. PCR-uncorrected ACPR rates were comparable in both groups (AMP: 98.2%, AL: 99.4% on Day 28, p=0.352; AMP: 98.2%, AL: 98.8% on Day 42, p=0.674). No significant differences in FCT and PCT were observed between the groups. No drug-related adverse events (AEs) or severe AEs were reported.

Conclusion: Once-daily dosing of AMP demonstrates comparable efficacy and safety to standard twice-daily dosing of AL in the treatment of uncomplicated P. falciparum malaria.

Trial id: Pan African Clinical Trials Registry - PACTR202305878745601 (prospectively registered on 22^nd May 2023), URL: pactr.samrc.ac.za/Search.aspx.