Safety and Efficacy of Single Dose versus Multiple Doses of AmBisome® for Treatment of Visceral Leishmaniasis in Eastern Africa: A Randomised Trial
Publication Date
January 16, 2014
Journal
PLOS Neglected Tropical Diseases
Authors
Eltahir A. G. Khalil, Teklu Weldegebreal, Brima M. Younis, Raymond Omollo, et al
Volume
8
Issue
1
Pages
e2613
DOI
https://dx.plos.org/10.1371/journal.pntd.0002613
Publisher URL
http://journals.plos.org/plosntds/article?id=10.1371%2Fjournal.pntd.0002613
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/24454970
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3894173
Europe PMC
http://europepmc.org/abstract/MED/24454970
Web of Science
000337977300019
Scopus
84906922834
Mendeley
http://www.mendeley.com/research/safety-efficacy-single-dose-versus-multiple-doses-ambisome-treatment-visceral-leishmaniasis-eastern-7
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Mendeley | Further Information

{"title"=>"Safety and Efficacy of Single Dose versus Multiple Doses of AmBisome® for Treatment of Visceral Leishmaniasis in Eastern Africa: A Randomised Trial", "type"=>"journal", "authors"=>[{"first_name"=>"Eltahir A. G.", "last_name"=>"Khalil"}, {"first_name"=>"Teklu", "last_name"=>"Weldegebreal"}, {"first_name"=>"Brima M.", "last_name"=>"Younis"}, {"first_name"=>"Raymond", "last_name"=>"Omollo"}, {"first_name"=>"Ahmed M.", "last_name"=>"Musa"}, {"first_name"=>"Workagegnehu", "last_name"=>"Hailu"}, {"first_name"=>"Abuzaid A.", "last_name"=>"Abuzaid"}, {"first_name"=>"Thomas P. C.", "last_name"=>"Dorlo"}, {"first_name"=>"Zewdu", "last_name"=>"Hurissa"}, {"first_name"=>"Sisay", "last_name"=>"Yifru"}, {"first_name"=>"William", "last_name"=>"Haleke"}, {"first_name"=>"Peter G.", "last_name"=>"Smith"}, {"first_name"=>"Sally", "last_name"=>"Ellis"}, {"first_name"=>"Manica", "last_name"=>"Balasegaram"}, {"first_name"=>"Ahmed M.", "last_name"=>"EL-Hassan"}, {"first_name"=>"Gerard J.", "last_name"=>"Schoone"}, {"first_name"=>"Monique", "last_name"=>"Wasunna"}, {"first_name"=>"Robert", "last_name"=>"Kimutai"}, {"first_name"=>"Tansy", "last_name"=>"Edwards"}, {"first_name"=>"Asrat", "last_name"=>"Hailu"}], "year"=>2014, "source"=>"PLoS Neglected Tropical Diseases", "identifiers"=>{"doi"=>"10.1371/journal.pntd.0002613", "pmid"=>"24454970", "issn"=>"1935-2735", "isbn"=>"1935-2727\\r1935-2735"}, "id"=>"bdc30772-1494-3743-a2b6-bed1bf478e3a", "abstract"=>"BACKGROUND: Anti-leishmanial drug regimens that include a single dose AmBisome could be suitable for eastern African patients with symptomatic visceral leishmaniasis (VL) but the appropriate single dose is unknown.\\n\\nMETHODOLOGY: A multi-centre, open-label, non-inferiority, randomized controlled trial with an adaptive design, was conducted to compare the efficacy and safety of a single dose and multiple doses of AmBisome for the treatment of VL in eastern Africa. The primary efficacy endpoint was definitive cure (DC) at 6 months. Symptomatic patients with parasitologically-confirmed, non-severe VL, received a single dose of AmBisome 7.5 mg/kg body weight or multiple doses, 7 times 3 mg/kg on days 1-5, 14, and 21. If interim analyses, evaluated 30 days after the start of treatment following 40 or 80 patients, showed the single dose gave significantly poorer parasite clearance than multiple doses at the 5% significance level, the single dose was increased by 2·5 mg/kg. In a sub-set of patients, parasite clearance was measured by quantitative reverse transcriptase (qRT) PCR.\\n\\nPRINCIPAL FINDINGS: The trial was terminated after the third interim analysis because of low efficacy of both regimens. Based on the intention-to-treat population, DC was 85% (95%CI 73-93%), 40% (95%CI 19-64%), and 58% (95%CI 41-73%) in patients treated with multiple doses (n = 63), and single doses of 7·5 (n = 21) or 10 mg/kg (n = 40), respectively. qRT-PCR suggested superior parasite clearance with multiple doses as early as day 3. Safety data accorded with the drug label.\\n\\nCONCLUSIONS: The tested AmBisome regimens would not be suitable for VL treatment across eastern Africa. An optimal single dose regimen was not identified.\\n\\nTRIALS REGISTRATION: www.clinicaltrials.govNCT00832208.", "link"=>"http://www.mendeley.com/research/safety-efficacy-single-dose-versus-multiple-doses-ambisome-treatment-visceral-leishmaniasis-eastern-7", "reader_count"=>45, "reader_count_by_academic_status"=>{"Unspecified"=>3, "Professor > Associate Professor"=>4, "Researcher"=>8, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>2, "Student > Master"=>8, "Other"=>3, "Student > Bachelor"=>1, "Lecturer"=>1, "Professor"=>2}, "reader_count_by_user_role"=>{"Unspecified"=>3, "Professor > Associate Professor"=>4, "Researcher"=>8, "Student > Doctoral Student"=>3, "Student > Ph. D. Student"=>10, "Student > Postgraduate"=>2, "Student > Master"=>8, "Other"=>3, "Student > Bachelor"=>1, "Lecturer"=>1, "Professor"=>2}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Agricultural and Biological Sciences"=>7, "Arts and Humanities"=>1, "Business, Management and Accounting"=>2, "Veterinary Science and Veterinary Medicine"=>1, "Chemistry"=>4, "Biochemistry, Genetics and Molecular Biology"=>1, "Nursing and Health Professions"=>1, "Mathematics"=>2, "Medicine and Dentistry"=>15, "Pharmacology, Toxicology and Pharmaceutical Science"=>1, "Psychology"=>1, "Social Sciences"=>2, "Immunology and Microbiology"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>15}, "Social Sciences"=>{"Social Sciences"=>2}, "Psychology"=>{"Psychology"=>1}, "Mathematics"=>{"Mathematics"=>2}, "Unspecified"=>{"Unspecified"=>5}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>1}, "Arts and Humanities"=>{"Arts and Humanities"=>1}, "Chemistry"=>{"Chemistry"=>4}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>2}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>7}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Veterinary Science and Veterinary Medicine"=>{"Veterinary Science and Veterinary Medicine"=>1}}, "reader_count_by_country"=>{"Brazil"=>1, "Switzerland"=>2, "Germany"=>1, "Spain"=>1, "India"=>1}, "group_count"=>3}

CrossRef

Scopus | Further Information

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Figshare

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  • {"files"=>["https://ndownloader.figshare.com/files/1349394"], "description"=>"<p>Interim analyses were based on day 30 cure in the Intention-to-Treat (ITT) population. iv intravenous, mg/kg/day milligram/kilogram body weight/day.</p>", "links"=>[], "tags"=>[], "article_id"=>902590, "categories"=>["Medicine"], "users"=>["Eltahir A. G. Khalil", "Teklu Weldegebreal", "Brima M. Younis", "Raymond Omollo", "Ahmed M. Musa", "Workagegnehu Hailu", "Abuzaid A. Abuzaid", "Thomas P. C. Dorlo", "Zewdu Hurissa", "Sisay Yifru", "William Haleke", "Peter G. Smith", "Sally Ellis", "Manica Balasegaram", "Ahmed M. EL-Hassan", "Gerard J. Schoone", "Monique Wasunna", "Robert Kimutai", "Tansy Edwards", "Asrat Hailu"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002613.g002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Summary_of_study_design_/902590", "title"=>"Summary of study design.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-01-16 03:19:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1349395"], "description"=>"<p>Comparison of parasite clearance rates from peripheral blood in single (10 mg/kg) and multiple dose (7×3 mg/kg) regimens of AmBisome®. Data are from 5 consenting patients in each of the 10 mg/kg single-dose and multiple-dose arms.</p>", "links"=>[], "tags"=>["clearance", "peripheral"], "article_id"=>902591, "categories"=>["Medicine"], "users"=>["Eltahir A. G. Khalil", "Teklu Weldegebreal", "Brima M. Younis", "Raymond Omollo", "Ahmed M. Musa", "Workagegnehu Hailu", "Abuzaid A. Abuzaid", "Thomas P. C. Dorlo", "Zewdu Hurissa", "Sisay Yifru", "William Haleke", "Peter G. Smith", "Sally Ellis", "Manica Balasegaram", "Ahmed M. EL-Hassan", "Gerard J. Schoone", "Monique Wasunna", "Robert Kimutai", "Tansy Edwards", "Asrat Hailu"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002613.g003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Parasite_clearance_from_peripheral_blood_/902591", "title"=>"Parasite clearance from peripheral blood.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2014-01-16 03:19:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1349396"], "description"=>"<p>Intention-to-Treat and Per-Protocol complete-case analysis populations were identical at day 30 & day 210.</p><p>Exact binomial 95% confidence interval (CI).</p><p>One-sided 97.5% confidence interval.</p><p>Multiple versus 7.5 mg/kg single dose; p-value = 0.015 (Fisher's exact test): Dose escalation rule met; increase dosage to 10 mg/kg & continue recruitment.</p><p>Multiple versus 10 mg/kg single dose; p value = 0.748 from chi-square test of difference between arms: Dose escalation rule not met; continue recruitment (same dosage in single-dose arm).</p><p>Includes patients in Interim analysis 2. Multiple versus 10 mg/kg single dose; p-value = 0.196 from chi-square test of difference between arms: Dose escalation rule not met; concerns arose regarding low cure in each arm and recruitment not continued.</p><p>8 patients lost to follow-up by day 210 (all from the multiple-dose arm).</p>", "links"=>[], "tags"=>["non-comparative", "efficacy"], "article_id"=>902592, "categories"=>["Medicine"], "users"=>["Eltahir A. G. Khalil", "Teklu Weldegebreal", "Brima M. Younis", "Raymond Omollo", "Ahmed M. Musa", "Workagegnehu Hailu", "Abuzaid A. Abuzaid", "Thomas P. C. Dorlo", "Zewdu Hurissa", "Sisay Yifru", "William Haleke", "Peter G. Smith", "Sally Ellis", "Manica Balasegaram", "Ahmed M. EL-Hassan", "Gerard J. Schoone", "Monique Wasunna", "Robert Kimutai", "Tansy Edwards", "Asrat Hailu"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002613.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Interim_analyses_and_non_comparative_efficacy_analysis_for_primary_day_210_and_secondary_day_30_end_points_/902592", "title"=>"Interim analyses and non-comparative efficacy analysis for primary (day 210) and secondary (day 30) end points.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-01-16 03:19:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1349397"], "description"=>"<p>TEADR = treatment emergent adverse drug reaction; treatment emergent = onset between day 1 and day 60 inclusive; adverse drug reaction if investigator judged relationship to treatment as “probable”, “possible” or “unlikely”.</p><p>This includes patients with infusion related reactions.</p><p>Renal impairment: 3 mild cases and 1 moderate as graded by investigator, all resolved during study period.</p>", "links"=>[], "tags"=>["drug-related", "emergent"], "article_id"=>902593, "categories"=>["Medicine"], "users"=>["Eltahir A. G. Khalil", "Teklu Weldegebreal", "Brima M. Younis", "Raymond Omollo", "Ahmed M. Musa", "Workagegnehu Hailu", "Abuzaid A. Abuzaid", "Thomas P. C. Dorlo", "Zewdu Hurissa", "Sisay Yifru", "William Haleke", "Peter G. Smith", "Sally Ellis", "Manica Balasegaram", "Ahmed M. EL-Hassan", "Gerard J. Schoone", "Monique Wasunna", "Robert Kimutai", "Tansy Edwards", "Asrat Hailu"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002613.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Infusion_related_and_drug_related_treatment_emergent_AEs_/902593", "title"=>"Infusion-related and drug-related treatment emergent AEs.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-01-16 03:19:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1349398"], "description"=>"<p>Data are n (%) or means (SD). AST aspartate aminotransferase, ALT alanine aminotransferase.</p><p>classified using weight for height and BMI for age in those aged ≤19 years and BMI in those aged >19: normal if −2SD≤ weight for height or BMI for age <+1SD or 18.5≤BMI<25.0; underweight if −3SD≤ weight for height or BMI for age <−2SD or 16.0≤BMI<18.5; severely underweight if weight for height or BMI for age <−3SD or BMI<16.0.</p><p>1 case of unconfirmed VL with no parasites detected (major protocol deviation, excluded from analysis) and one case of no parasite count recorded on a log scale in which VL was confirmed by lymph node aspirate.</p><p>no parasite count recorded on a log scale in which VL was confirmed by lymph node aspirate.</p>", "links"=>[], "tags"=>[], "article_id"=>902594, "categories"=>["Medicine"], "users"=>["Eltahir A. G. Khalil", "Teklu Weldegebreal", "Brima M. Younis", "Raymond Omollo", "Ahmed M. Musa", "Workagegnehu Hailu", "Abuzaid A. Abuzaid", "Thomas P. C. Dorlo", "Zewdu Hurissa", "Sisay Yifru", "William Haleke", "Peter G. Smith", "Sally Ellis", "Manica Balasegaram", "Ahmed M. EL-Hassan", "Gerard J. Schoone", "Monique Wasunna", "Robert Kimutai", "Tansy Edwards", "Asrat Hailu"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002613.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Baseline_data_on_patient_demographics_clinical_characteristics_and_laboratory_values_/902594", "title"=>"Baseline data on patient demographics, clinical characteristics and laboratory values.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2014-01-16 03:19:08"}
  • {"files"=>["https://ndownloader.figshare.com/files/1349399", "https://ndownloader.figshare.com/files/1349400"], "description"=>"<div><p>Background</p><p>Anti-leishmanial drug regimens that include a single dose AmBisome® could be suitable for eastern African patients with symptomatic visceral leishmaniasis (VL) but the appropriate single dose is unknown.</p><p>Methodology</p><p>A multi-centre, open-label, non-inferiority, randomized controlled trial with an adaptive design, was conducted to compare the efficacy and safety of a single dose and multiple doses of AmBisome® for the treatment of VL in eastern Africa. The primary efficacy endpoint was definitive cure (DC) at 6 months. Symptomatic patients with parasitologically-confirmed, non-severe VL, received a single dose of AmBisome® 7.5 mg/kg body weight or multiple doses, 7 times 3 mg/kg on days 1–5, 14, and 21. If interim analyses, evaluated 30 days after the start of treatment following 40 or 80 patients, showed the single dose gave significantly poorer parasite clearance than multiple doses at the 5% significance level, the single dose was increased by 2·5 mg/kg. In a sub-set of patients, parasite clearance was measured by quantitative reverse transcriptase (qRT) PCR.</p><p>Principal Findings</p><p>The trial was terminated after the third interim analysis because of low efficacy of both regimens. Based on the intention-to-treat population, DC was 85% (95%CI 73–93%), 40% (95%CI 19–64%), and 58% (95%CI 41–73%) in patients treated with multiple doses (n = 63), and single doses of 7·5 (n = 21) or 10 mg/kg (n = 40), respectively. qRT-PCR suggested superior parasite clearance with multiple doses as early as day 3. Safety data accorded with the drug label.</p><p>Conclusions</p><p>The tested AmBisome® regimens would not be suitable for VL treatment across eastern Africa. An optimal single dose regimen was not identified.</p><p>Trials Registration</p><p> <a href=\"http://www.clinicaltrials.gov\" target=\"_blank\">www.clinicaltrials.gov</a><a href=\"http://clinicaltrials.gov/ct2/show/NCT00832208?term=NCT00832208&rank=1\" target=\"_blank\">NCT00832208</a></p></div>", "links"=>[], "tags"=>["efficacy", "doses", "visceral", "leishmaniasis", "randomised"], "article_id"=>902595, "categories"=>["Medicine"], "users"=>["Eltahir A. G. Khalil", "Teklu Weldegebreal", "Brima M. Younis", "Raymond Omollo", "Ahmed M. Musa", "Workagegnehu Hailu", "Abuzaid A. Abuzaid", "Thomas P. C. Dorlo", "Zewdu Hurissa", "Sisay Yifru", "William Haleke", "Peter G. Smith", "Sally Ellis", "Manica Balasegaram", "Ahmed M. EL-Hassan", "Gerard J. Schoone", "Monique Wasunna", "Robert Kimutai", "Tansy Edwards", "Asrat Hailu"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0002613.s001", "https://dx.doi.org/10.1371/journal.pntd.0002613.s002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Safety_and_Efficacy_of_Single_Dose_versus_Multiple_Doses_of_AmBisome_174_for_Treatment_of_Visceral_Leishmaniasis_in_Eastern_Africa_A_Randomised_Trial_/902595", "title"=>"Safety and Efficacy of Single Dose versus Multiple Doses of AmBisome® for Treatment of Visceral Leishmaniasis in Eastern Africa: A Randomised Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2014-01-16 03:19:08"}

PMC Usage Stats | Further Information

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