title: Arterolane maleate plus piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: a comparative, multicenter, randomized clinical trial.
abstract: BACKGROUND
  Artemisinin-based combination therapy is the first-line treatment for uncomplicated falciparum malaria. This study assessed the antimalarial efficacy and safety of a combination of 150 mg of arterolane maleate and 750 mg of piperaquine phosphate (AM-PQP) in comparison to Coartem (artemether and lumefantrine) in patients with acute uncomplicated P. falciparum malaria.
  
  
  METHODS
  In this open-label, randomized, multicentric, parallel group clinical trial, 240 patients were randomized to receive AM-PQP (160 patients) or Coartem (80 patients). Patients with P. falciparum monoinfection and initial parasite densities ranging from 1000 to 100 000 asexual parasites/µL of blood were followed for 28 days. Polymerase chain reaction-corrected adequate clinical and parasitologic response on day 28, parasite clearance time, and fever clearance time were evaluated.
  
  
  RESULTS
  A total of 151 (94.4%) of 160 patients in the AM-PQP group completed the trial, while 77 (96.3%) of 80 patients in the Coartem group completed the trial. No treatment failure was noted in the AM-PQP group, while one patient receiving Coartem failed treatment on day 28. There was no difference in the median parasite clearance time (30 hours in both groups) or median fever clearance time (24 hours in both groups) after administration of the 2 study treatments.
  
  
  CONCLUSIONS
  The available data support the evaluation of a drug combination in a larger population as a fixed-dose combination. Clinical Trials Registration. CTRI/2007/091/000031.
authors.affiliation: National Institute of Malaria Research, New Delhi, India.
authors.forename: Neena
authors.initials: N
authors.lastname: Valecha
authors.forename: Srivicha
authors.initials: S
authors.lastname: Krudsood
authors.forename: Noppadon
authors.initials: N
authors.lastname: Tangpukdee
authors.forename: Sanjib
authors.initials: S
authors.lastname: Mohanty
authors.forename: S K
authors.initials: SK
authors.lastname: Sharma
authors.forename: P K
authors.initials: PK
authors.lastname: Tyagi
authors.forename: Anupkumar
authors.initials: A
authors.lastname: Anvikar
authors.forename: Rajesh
authors.initials: R
authors.lastname: Mohanty
authors.forename: B S
authors.initials: BS
authors.lastname: Rao
authors.forename: A C
authors.initials: AC
authors.lastname: Jha
authors.forename: B
authors.initials: B
authors.lastname: Shahi
authors.forename: Jai Prakash Narayan
authors.initials: JP
authors.lastname: Singh
authors.forename: Arjun
authors.initials: A
authors.lastname: Roy
authors.forename: Pawandeep
authors.initials: P
authors.lastname: Kaur
authors.forename: Monica
authors.initials: M
authors.lastname: Kothari
authors.forename: Shantanu
authors.initials: S
authors.lastname: Mehta
authors.forename: Anirudh
authors.initials: A
authors.lastname: Gautam
authors.forename: Jyoti K
authors.initials: JK
authors.lastname: Paliwal
authors.forename: Sudershan
authors.initials: S
authors.lastname: Arora
authors.forename: Nilanjan
authors.initials: N
authors.lastname: Saha
mesh_terms: D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D006573:Heterocyclic Compounds, 1-Ring / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D053208:Kaplan-Meier Estimate; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000378:metabolism / Q000469:parasitology; D008297:Male; D010545:Peroxides / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011804:Quinolines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013141:Spiro Compounds / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D010879:Piperazines
chemical_list: D000962:Antimalarials; D006573:Heterocyclic Compounds, 1-Ring; D010545:Peroxides; D011804:Quinolines; D013141:Spiro Compounds; C489136:arterolane; C034759:piperaquine; D010879:Piperazines