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Volumn 15, Issue 1, 2016, Pages

Comparison of the safety and efficacy of fixed-dose combination of arterolane maleate and piperaquine phosphate with chloroquine in acute, uncomplicated Plasmodium vivax malaria: A phase III, multicentric, open-label study

(18)  Valecha, Neena a   Savargaonkar, Deepali a   Srivastava, Bina a   Rao, B H Krishnamoorthy b   Tripathi, Santanu K c   Gogtay, Nithya d   Kochar, Sanjay Kumar e   Kumar, Nalli Babu Vijaya f   Rajadhyaksha, Girish Chandra g   Lakhani, Jitendra D h   Solanki, Bhagirath B i   Jalali, Rajinder K j   Arora, Sudershan j   Roy, Arjun j   Saha, Nilanjan j   Iyer, Sunil S j   Sharma, Pradeep j   Anvikar, Anupkumar R a  


Author keywords

Arterolane maleate and piperaquine phosphate; Chloroquine; Cure rate; Fever clearance time; Fixed dose combination; Parasite clearance time; Pharmacokinetics; Plasmodium vivax; Primary efficacy analysis

Indexed keywords

ANTIMALARIAL AGENT; ARTEROLANE MALEATE PLUS PIPERAQUINE PHOSPHATE; CHLOROQUINE; UNCLASSIFIED DRUG; ARTEROLANE; MALEIC ACID DERIVATIVE; PEROXIDE; PIPERAQUINE; QUINOLINE DERIVATIVE; SINGLE HETEROCYCLIC RINGS; SPIRO COMPOUND;

EID: 84961352460     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/s12936-016-1084-1     Document Type: Article
Times cited : (26)

References (27)
  • 1
    • 31444454856 scopus 로고    scopus 로고
    • WHO Geneva: World Health Organization
    • WHO. Guidelines for the treatment of malaria (second edition). Geneva: World Health Organization; 2010. [ http://whqlibdoc.who.int/publications/2010/9789241547925-eng.pdf ].
    • (2010) Guidelines for the Treatment of Malaria (Second Edition)
  • 2
    • 84870424373 scopus 로고    scopus 로고
    • Monitoring antimalarial drug resistance in India via sentinel sites: Outcomes and risk factors for treatment failure, 2009-2010
    • Mishra N, Singh JP, Srivastava B, Arora U, Shah NK, Ghosh SK, et al. Monitoring antimalarial drug resistance in India via sentinel sites: outcomes and risk factors for treatment failure, 2009-2010. Bull World Health Organ. 2012;90:895-904. doi: 10.2471/BLT.12.109124 (Epub 2012 Oct 31).
    • (2012) Bull World Health Organ , vol.90 , pp. 895-904
    • Mishra, N.1    Singh, J.P.2    Srivastava, B.3    Arora, U.4    Shah, N.K.5    Ghosh, S.K.6
  • 3
    • 0030448401 scopus 로고    scopus 로고
    • Chloroquine resistant 22. Plasmodium vivax malaria in India
    • 1:STN:280:DyaK2s7jsFSgtA%3D%3D 8980595
    • Dua VK, Kar PK, Sharma VP. Chloroquine resistant 22. Plasmodium vivax malaria in India. Trop Med Int Health. 1996;1:816-9.
    • (1996) Trop Med Int Health , vol.1 , pp. 816-819
    • Dua, V.K.1    Kar, P.K.2    Sharma, V.P.3
  • 4
    • 7244251635 scopus 로고    scopus 로고
    • Chloroquine resistance in Plasmodium vivax
    • 525399 1:CAS:528:DC%2BD2cXpvVyksr8%3D 15504824
    • Baird JK. Chloroquine resistance in Plasmodium vivax. Antimicrob Agents Chemother. 2004;48:4075-83.
    • (2004) Antimicrob Agents Chemother , vol.48 , pp. 4075-4083
    • Baird, J.K.1
  • 5
    • 84893007723 scopus 로고    scopus 로고
    • Geneva: World Health Organization
    • WHO. World Malaria Report. Geneva: World Health Organization. 2013.
    • (2013) World Malaria Report
  • 10
    • 56349124229 scopus 로고    scopus 로고
    • Chloroquine-resistant: Plasmodium vivax malaria in Debre Zeit, Ethiopia
    • 2584068 18959774
    • Teka H, Petros B, Yamuah L, Tesfaye G, Elhassan I, Muchohi S, et al. Chloroquine-resistant: Plasmodium vivax malaria in Debre Zeit, Ethiopia. Malar J. 2008;7:220.
    • (2008) Malar J , vol.7 , pp. 220
    • Teka, H.1    Petros, B.2    Yamuah, L.3    Tesfaye, G.4    Elhassan, I.5    Muchohi, S.6
  • 11
    • 0004157786 scopus 로고    scopus 로고
    • World Health Organization Geneva, Switzerland. 3-5 December
    • World Health Organization. Monitoring antimalarial drug resistance. Report of a WHO consultation. Geneva, Switzerland. 3-5 December. 2001. [ http://malaria.who.int/cmc-upload/0/000/015/800/200239.html ].
    • (2001) Monitoring Antimalarial Drug Resistance. Report of A WHO Consultation
  • 12
    • 70049117393 scopus 로고    scopus 로고
    • Artemisinin-based combination therapy for treating uncomplicated malaria
    • DOI: 10.1002/14651858.CD007483.pub2
    • Sinclair D, Zani B, Donegan S, Olliaro P, Garner P. Artemisinin-based combination therapy for treating uncomplicated malaria. Cochrane Database Syst Rev. 2009; 3:CD007483. DOI: 10.1002/14651858.CD007483.pub2.
    • (2009) Cochrane Database Syst Rev , vol.3 , pp. CD007483
    • Sinclair, D.1    Zani, B.2    Donegan, S.3    Olliaro, P.4    Garner, P.5
  • 13
    • 33846849862 scopus 로고    scopus 로고
    • Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: Open label randomized comparison
    • 2532500 1:CAS:528:DC%2BD2sXisVWhs7k%3D 17336652
    • Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, et al. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: open label randomized comparison. Lancet. 2007;369:757-65.
    • (2007) Lancet , vol.369 , pp. 757-765
    • Ratcliff, A.1    Siswantoro, H.2    Kenangalem, E.3    Maristela, R.4    Wuwung, R.M.5    Laihad, F.6
  • 15
    • 84898660982 scopus 로고    scopus 로고
    • Safety, tolerability and pharmacokinetic profile of single and multiple oral doses of arterolane (RBx11160) maleate in healthy subjects
    • Saha N1, Moehrle JJ, Zutshi A, Sharma P, Kaur P, Iyer SS. Safety, tolerability and pharmacokinetic profile of single and multiple oral doses of arterolane (RBx11160) maleate in healthy subjects. J Clin Pharmacol. 2014;54:386-93.
    • (2014) J Clin Pharmacol , vol.54 , pp. 386-393
    • Saha, N.1    Moehrle, J.J.2    Zutshi, A.3    Sharma, P.4    Kaur, P.5    Iyer, S.S.6
  • 16
    • 38349174133 scopus 로고    scopus 로고
    • Safety, tolerability, and single- and multiple-dose pharmacokinetics of piperaquine phosphate in healthy subjects
    • 1:CAS:528:DC%2BD1cXisVOqtbY%3D 18199893
    • Ahmed T, Sharma P, Gautam A, Varshney B, Kothari M, Ganguly S, et al. Safety, tolerability, and single- and multiple-dose pharmacokinetics of piperaquine phosphate in healthy subjects. J Clin Pharmacol. 2008;48:166-75.
    • (2008) J Clin Pharmacol , vol.48 , pp. 166-175
    • Ahmed, T.1    Sharma, P.2    Gautam, A.3    Varshney, B.4    Kothari, M.5    Ganguly, S.6
  • 17
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM). May
    • Guidance for industry, bioanalytical method validation. US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM). May 2001.
    • (2001) Guidance for Industry, Bioanalytical Method Validation
  • 18
    • 0034967932 scopus 로고    scopus 로고
    • The neglected burden of Plasmodium vivax malaria
    • 1:STN:280:DC%2BD3MzmsVOjuw%3D%3D 11425182
    • Mendis K, Sina BJ, Marchesini P, Carter R. The neglected burden of Plasmodium vivax malaria. Am J Trop Med Hyg. 2001;64(1-2 Suppl):97-106.
    • (2001) Am J Trop Med Hyg , vol.64 , Issue.1-2 , pp. 97-106
    • Mendis, K.1    Sina, B.J.2    Marchesini, P.3    Carter, R.4
  • 19
    • 33846783000 scopus 로고    scopus 로고
    • Therapeutic response of multidrug-resistant Plasmodium falciparum and P. Vivax to chloroquine and sulfadoxine-pyrimethamine in southern Papua, Indonesia
    • 2080856 1:CAS:528:DC%2BD2sXjvVOrsLg%3D 17028048
    • Ratcliff A, Siswantoro H, Kenangalem E, Wuwung M, Brockman A. Therapeutic response of multidrug-resistant Plasmodium falciparum and P. vivax to chloroquine and sulfadoxine-pyrimethamine in southern Papua, Indonesia. Trans R Soc Trop Med Hyg. 2007;101:351-9.
    • (2007) Trans R Soc Trop Med Hyg , vol.101 , pp. 351-359
    • Ratcliff, A.1    Siswantoro, H.2    Kenangalem, E.3    Wuwung, M.4    Brockman, A.5
  • 21
    • 0029843392 scopus 로고    scopus 로고
    • Clinical pharmacology and therapeutic potential of artemisinin and its derivatives in the treatment of malaria
    • deVries PJ, Dien TK: Clinical pharmacology and therapeutic potential of artemisinin and its derivatives in the treatment of malaria. Drugs 1996;52: 818-36.
    • (1996) Drugs , vol.52 , pp. 818-836
    • DeVries, P.J.1    Dien, T.K.2
  • 22
    • 84864962615 scopus 로고    scopus 로고
    • Arterolane maleate plus piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: A comparative, multicenter, randomized clinical trial
    • 1:CAS:528:DC%2BC38Xht1ajsr%2FJ 22586253
    • Valecha N, Krudsood S, Tangpukdee N, Mohanty S, Sharma SK, Tyagi PK, et al. Arterolane maleate plus piperaquine phosphate for treatment of uncomplicated Plasmodium falciparum malaria: a comparative, multicenter, randomized clinical trial. Clin Infect Dis. 2012;55:663-71.
    • (2012) Clin Infect Dis , vol.55 , pp. 663-671
    • Valecha, N.1    Krudsood, S.2    Tangpukdee, N.3    Mohanty, S.4    Sharma, S.K.5    Tyagi, P.K.6
  • 24
    • 84867625220 scopus 로고    scopus 로고
    • Therapeutic efficacy of artemether-lumefantrine for Plasmodium vivax infections in a prospective study in Guyana
    • 3488321 1:CAS:528:DC%2BC38XhvVCjs7zL 23083017
    • Eibach D, Ceron N, Krishnalall K, Carter K, Bonnot G, Bienvenu AL, et al. Therapeutic efficacy of artemether-lumefantrine for Plasmodium vivax infections in a prospective study in Guyana. Malar J. 2012;11:347.
    • (2012) Malar J , vol.11 , pp. 347
    • Eibach, D.1    Ceron, N.2    Krishnalall, K.3    Carter, K.4    Bonnot, G.5    Bienvenu, A.L.6
  • 25
    • 35748964160 scopus 로고    scopus 로고
    • Electrocardiographic safety evaluation of dihydroartemisinin-piperaquine in the treatment of uncomplicated falciparum malaria
    • 17827358
    • Mytton OT, Ashley EA, Peto L, Price RN, La Y, Hae R, et al. Electrocardiographic safety evaluation of dihydroartemisinin-piperaquine in the treatment of uncomplicated falciparum malaria. Am J Trop Med Hyg. 2007;77:447-50.
    • (2007) Am J Trop Med Hyg , vol.77 , pp. 447-450
    • Mytton, O.T.1    Ashley, E.A.2    Peto, L.3    Price, R.N.4    La, Y.5    Hae, R.6
  • 26
    • 0142209158 scopus 로고    scopus 로고
    • Drug induced QT prolongation and Torsades de Pointes
    • 1767957 1:CAS:528:DC%2BD3sXptleit78%3D 14594906
    • Yap YG, Camm AJ. Drug induced QT prolongation and Torsades de Pointes. Heart. 2003;89:1363-72.
    • (2003) Heart , vol.89 , pp. 1363-1372
    • Yap, Y.G.1    Camm, A.J.2
  • 27
    • 0027989757 scopus 로고
    • The pharmacokinetics of chloroquine in healthy Thai subjects and patients with Plasmodium vivax malaria
    • 1364802 1:CAS:528:DyaK2cXmsVGhtLs%3D 7826832
    • Na-Bangchang K, Limpaibul L, Thanavibul A, Tan-Ariya P, Karbwang J. The pharmacokinetics of chloroquine in healthy Thai subjects and patients with Plasmodium vivax malaria. Br J Clin Pharmacol. 1994;38:278-81.
    • (1994) Br J Clin Pharmacol , vol.38 , pp. 278-281
    • Na-Bangchang, K.1    Limpaibul, L.2    Thanavibul, A.3    Tan-Ariya, P.4    Karbwang, J.5


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