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Artemether\u2013lumefantrine (AL) is the most commonly used ACT for treatment of falciparum malaria in Africa but there is limited evidence on the safety and efficacy of AL in HIV-infected individuals on ART, among whom drug\u2013drug interactions are expected. Day-42 adequate clinical and parasitological response (ACPR) and incidence of adverse events was assessed in HIV-infected individuals on efavirenz-based ART with uncomplicated falciparum malaria treated with AL.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A prospective, open label, non-randomized, interventional clinical trial was conducted at St Paul\u2019s Hospital in northern Zambia, involving 152 patients aged 15\u201365\u00a0years with uncomplicated falciparum malaria, who were on efavirenz-based ART. They received a 3-day directly observed standard treatment of AL and were followed up until day 63. Day-42 polymerase chain reaction (PCR)-corrected ACPRs (95% confidence interval [CI]) were calculated for the intention-to-treat population.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Enrolled patients had a baseline geometric mean (95% CI) parasite density of 1108 (841\u20131463) parasites\/\u00b5L; 16.4% (25\/152) of the participants had a recurrent malaria episode by day 42. However, PCR data was available for 17 out of the 25 patients who had malaria recurrence. Among all the 17 patients, PCR findings demonstrated malaria re-infection, making the PCR-adjusted day-42 ACPR 100% in the 144 patients who could be evaluated. Even when eight patients with missing PCR data were considered very conservatively as failures, the day-42 ACPR was over 94%. None of the participants, disease or treatment characteristics, including day-7 lumefantrine concentrations, predicted the risk of malaria recurrence by day 42. AL was well tolerated following administration. There were only two cases of grade 3 neutropaenia and one serious adverse event of lobar pneumonia, none of which was judged as probably related to intake of AL.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>AL was well tolerated and efficacious in treating uncomplicated falciparum malaria in HIV co-infected adults on efavirenz-based ART. However, a higher than anticipated proportion of participants experienced malaria re-infection, which highlights the need for additional malaria prevention measures in this sub-population after treatment with AL.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> Pan African Clinical Trials Registry (PACTR): PACTR201311000659400. Registered on 4 October 2013. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/pactr.samrc.ac.za\/Search.aspx\">https:\/\/pactr.samrc.ac.za\/Search.aspx<\/jats:ext-link><\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12936-019-2818-7","type":"journal-article","created":{"date-parts":[[2019,5,24]],"date-time":"2019-05-24T12:03:22Z","timestamp":1558699402000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy and safety of artemether\u2013lumefantrine as treatment for Plasmodium falciparum uncomplicated malaria in adult patients on efavirenz-based antiretroviral therapy in Zambia: an open label non-randomized interventional trial"],"prefix":"10.1186","volume":"18","clinical-trial-number":[{"clinical-trial-number":"pactr201311000659400","registry":"10.18810\/pactr"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0757-5259","authenticated-orcid":false,"given":"Clifford G.","family":"Banda","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mike","family":"Chaponda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mavuto","family":"Mukaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Modest","family":"Mulenga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastian","family":"Hachizovu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean B.","family":"Kabuya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joyce","family":"Mulenga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay","family":"Sikalima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Kalilani-Phiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dianne J.","family":"Terlouw","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saye H.","family":"Khoo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Lalloo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Mwapasa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,5,24]]},"reference":[{"key":"2818_CR1","doi-asserted-by":"publisher","first-page":"123","DOI":"10.2147\/RRTM.S154501","volume":"9","author":"TE Kwenti","year":"2018","unstructured":"Kwenti TE. 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Additional, ethics approvals were obtained from collaborating institutions in Malawi (College of Medicine Research and Ethics Committee) and United Kingdom (Liverpool School of Tropical Medicine Research Committee). Written informed consent was sought from all participants aged\u2009\u2265\u200918\u00a0years. Assent was sought from those who were aged\u2009<\u200918\u00a0years, except for \u201cmature minors\u201d.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Written informed consent to publish the data was sought from all participants aged\u2009\u2265\u200918\u00a0years. Assent was sought from those who were aged\u2009<\u200918\u00a0years, except for \u201cmature minors\u201d.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"180"}}