Incidence of malaria by cotrimoxazole use in HIV-infected Ugandan adults on antiretroviral therapy: a randomised, placebo-controlled study
Identifieur interne : 000319 ( Pmc/Curation ); précédent : 000318; suivant : 000320Incidence of malaria by cotrimoxazole use in HIV-infected Ugandan adults on antiretroviral therapy: a randomised, placebo-controlled study
Auteurs : Ronnie P. Kasirye [Ouganda, Royaume-Uni] ; Kathy Baisley [Royaume-Uni] ; Paula Munderi [Ouganda] ; Jonathan Levin [Ouganda, Afrique du Sud] ; Zacchaeus Anywaine [Ouganda] ; Andrew Nunn [Royaume-Uni] ; Anatoli Kamali [Ouganda] ; Heiner Grosskurth [Royaume-Uni]Source :
- AIDS (London, England) [ 0269-9370 ] ; 2016.
Abstract
Previous unblinded trials have shown increased malaria among HIV-infected adults on antiretroviral therapy (ART) who stop cotrimoxazole (CTX) prophylaxis. We investigated the effect of stopping CTX on malaria in HIV-infected adults on ART in a double-blind, placebo-controlled trial.
HIV-infected Ugandan adults stable on ART and CTX with CD4+ cell count at least 250 cells/μl were randomized (1 : 1) to continue CTX or stop CTX and receive matching placebo (COSTOP trial; ISRCTN44723643). Clinical malaria was defined as fever and a positive blood slide, and considered severe if a participant had at least one clinical or laboratory feature of severity or was admitted to hospital. Malaria incidence and rate ratios were estimated using random effects Poisson regression, accounting for multiple episodes.
A total of 2180 participants were enrolled and followed for a median of 2.5 years; 453 malaria episodes were recorded. Malaria incidence was 9.1/100 person-years (pyrs) [95% confidence interval (CI) = 8.2–10.1] and was higher on placebo (rate ratio 3.47; CI = 2.74–4.39). Malaria in the placebo arm decreased over time; although incidence remained higher than in the CTX arm, the difference between arms reduced slightly (interaction
HIV-infected adults – who are stable on ART and stop prophylactic CTX – experience more malaria than those that continue, but this difference is less than has been reported in previous trials. Few participants had severe malaria. Further research might be useful in identifying groups that can safely stop CTX prophylaxis.
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DOI: 10.1097/QAD.0000000000000956
PubMed: 26558729
PubMed Central: 4732005
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Kasirye</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Baisley, Kathy" sort="Baisley, Kathy" uniqKey="Baisley K" first="Kathy" last="Baisley">Kathy Baisley</name><affiliation wicri:level="1"><nlm:aff id="aff2">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Munderi, Paula" sort="Munderi, Paula" uniqKey="Munderi P" first="Paula" last="Munderi">Paula Munderi</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation></author><author><name sortKey="Levin, Jonathan" sort="Levin, Jonathan" uniqKey="Levin J" first="Jonathan" last="Levin">Jonathan Levin</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3">School of Public Health, University of Witwatersrand, Johannesburg, South Africa</nlm:aff><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>School of Public Health, University of Witwatersrand, Johannesburg</wicri:regionArea></affiliation></author><author><name sortKey="Anywaine, Zacchaeus" sort="Anywaine, Zacchaeus" uniqKey="Anywaine Z" first="Zacchaeus" last="Anywaine">Zacchaeus Anywaine</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation></author><author><name sortKey="Nunn, Andrew" sort="Nunn, Andrew" uniqKey="Nunn A" first="Andrew" last="Nunn">Andrew Nunn</name><affiliation wicri:level="1"><nlm:aff id="aff4">MRC Clinical Trials Unit at University College London, UK.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit at University College London</wicri:regionArea></affiliation></author><author><name sortKey="Kamali, Anatoli" sort="Kamali, Anatoli" uniqKey="Kamali A" first="Anatoli" last="Kamali">Anatoli Kamali</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation></author><author><name sortKey="Grosskurth, Heiner" sort="Grosskurth, Heiner" uniqKey="Grosskurth H" first="Heiner" last="Grosskurth">Heiner Grosskurth</name><affiliation wicri:level="1"><nlm:aff id="aff2">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26558729</idno><idno type="pmc">4732005</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732005</idno><idno type="RBID">PMC:4732005</idno><idno type="doi">10.1097/QAD.0000000000000956</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000319</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000319</idno><idno type="wicri:Area/Pmc/Curation">000319</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000319</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Incidence of malaria by cotrimoxazole use in HIV-infected Ugandan adults on antiretroviral therapy: a randomised, placebo-controlled study</title><author><name sortKey="Kasirye, Ronnie P" sort="Kasirye, Ronnie P" uniqKey="Kasirye R" first="Ronnie P." last="Kasirye">Ronnie P. Kasirye</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff2">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Baisley, Kathy" sort="Baisley, Kathy" uniqKey="Baisley K" first="Kathy" last="Baisley">Kathy Baisley</name><affiliation wicri:level="1"><nlm:aff id="aff2">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author><author><name sortKey="Munderi, Paula" sort="Munderi, Paula" uniqKey="Munderi P" first="Paula" last="Munderi">Paula Munderi</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation></author><author><name sortKey="Levin, Jonathan" sort="Levin, Jonathan" uniqKey="Levin J" first="Jonathan" last="Levin">Jonathan Levin</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff3">School of Public Health, University of Witwatersrand, Johannesburg, South Africa</nlm:aff><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>School of Public Health, University of Witwatersrand, Johannesburg</wicri:regionArea></affiliation></author><author><name sortKey="Anywaine, Zacchaeus" sort="Anywaine, Zacchaeus" uniqKey="Anywaine Z" first="Zacchaeus" last="Anywaine">Zacchaeus Anywaine</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation></author><author><name sortKey="Nunn, Andrew" sort="Nunn, Andrew" uniqKey="Nunn A" first="Andrew" last="Nunn">Andrew Nunn</name><affiliation wicri:level="1"><nlm:aff id="aff4">MRC Clinical Trials Unit at University College London, UK.</nlm:aff><country xml:lang="fr" wicri:curation="lc">Royaume-Uni</country><wicri:regionArea>MRC Clinical Trials Unit at University College London</wicri:regionArea></affiliation></author><author><name sortKey="Kamali, Anatoli" sort="Kamali, Anatoli" uniqKey="Kamali A" first="Anatoli" last="Kamali">Anatoli Kamali</name><affiliation wicri:level="1"><nlm:aff id="aff1">MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</nlm:aff><country xml:lang="fr">Ouganda</country><wicri:regionArea>MRC/UVRI Uganda Research Unit on AIDS, Entebbe</wicri:regionArea></affiliation></author><author><name sortKey="Grosskurth, Heiner" sort="Grosskurth, Heiner" uniqKey="Grosskurth H" first="Heiner" last="Grosskurth">Heiner Grosskurth</name><affiliation wicri:level="1"><nlm:aff id="aff2">London School of Hygiene and Tropical Medicine, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea></affiliation></author></analytic><series><title level="j">AIDS (London, England)</title><idno type="ISSN">0269-9370</idno><idno type="eISSN">1473-5571</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec sec-type="intro"><title>Introduction:</title><p>Previous unblinded trials have shown increased malaria among HIV-infected adults on antiretroviral therapy (ART) who stop cotrimoxazole (CTX) prophylaxis. We investigated the effect of stopping CTX on malaria in HIV-infected adults on ART in a double-blind, placebo-controlled trial.</p></sec><sec sec-type="methods"><title>Methods:</title><p>HIV-infected Ugandan adults stable on ART and CTX with CD4<sup>+</sup> cell count at least 250 cells/μl were randomized (1 : 1) to continue CTX or stop CTX and receive matching placebo (COSTOP trial; ISRCTN44723643). Clinical malaria was defined as fever and a positive blood slide, and considered severe if a participant had at least one clinical or laboratory feature of severity or was admitted to hospital. Malaria incidence and rate ratios were estimated using random effects Poisson regression, accounting for multiple episodes.</p></sec><sec sec-type="results"><title>Results:</title><p>A total of 2180 participants were enrolled and followed for a median of 2.5 years; 453 malaria episodes were recorded. Malaria incidence was 9.1/100 person-years (pyrs) [95% confidence interval (CI) = 8.2–10.1] and was higher on placebo (rate ratio 3.47; CI = 2.74–4.39). Malaria in the placebo arm decreased over time; although incidence remained higher than in the CTX arm, the difference between arms reduced slightly (interaction <italic>P</italic> value = 0.10). Fifteen participants experienced severe malaria (<1%); overall incidence was 0.30/100 pyrs (CI = 0.18–0.49). There was one malaria-related death (CTX arm).</p></sec><sec sec-type="conclusion"><title>Conclusion:</title><p>HIV-infected adults – who are stable on ART and stop prophylactic CTX – experience more malaria than those that continue, but this difference is less than has been reported in previous trials. Few participants had severe malaria. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">AIDS</journal-id><journal-id journal-id-type="iso-abbrev">AIDS</journal-id><journal-id journal-id-type="publisher-id">AIDS</journal-id><journal-title-group><journal-title>AIDS (London, England)</journal-title></journal-title-group><issn pub-type="ppub">0269-9370</issn><issn pub-type="epub">1473-5571</issn><publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26558729</article-id><article-id pub-id-type="pmc">4732005</article-id><article-id pub-id-type="doi">10.1097/QAD.0000000000000956</article-id><article-categories><subj-group subj-group-type="heading"><subject>Epidemiology and Social</subject></subj-group></article-categories><title-group><article-title>Incidence of malaria by cotrimoxazole use in HIV-infected Ugandan adults on antiretroviral therapy: a randomised, placebo-controlled study</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Kasirye</surname><given-names>Ronnie P.</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Baisley</surname><given-names>Kathy</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Munderi</surname><given-names>Paula</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Levin</surname><given-names>Jonathan</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref><xref ref-type="aff" rid="aff3"><sup>c</sup></xref></contrib><contrib contrib-type="author"><name><surname>Anywaine</surname><given-names>Zacchaeus</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Nunn</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="aff4"><sup>d</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kamali</surname><given-names>Anatoli</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Grosskurth</surname><given-names>Heiner</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib></contrib-group><aff id="aff1"><label>a</label>MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda</aff><aff id="aff2"><label>b</label>London School of Hygiene and Tropical Medicine, London, UK</aff><aff id="aff3"><label>c</label>School of Public Health, University of Witwatersrand, Johannesburg, South Africa</aff><aff id="aff4"><label>d</label>MRC Clinical Trials Unit at University College London, UK.</aff><author-notes><corresp>Correspondence to Ronnie P. Kasirye, MBChB, MSc, MRC/UVRI Uganda Research Unit on Aids, P.O. Box 49, Entebbe, Uganda. E-mail: <email>ronniekasirye@yahoo.com</email></corresp></author-notes><pub-date pub-type="ppub"><day>20</day><month>2</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>03</day><month>2</month><year>2016</year></pub-date><volume>30</volume><issue>4</issue><fpage>635</fpage><lpage>644</lpage><history><date date-type="received"><day>09</day><month>8</month><year>2015</year></date><date date-type="rev-recd"><day>12</day><month>10</month><year>2015</year></date><date date-type="accepted"><day>21</day><month>10</month><year>2015</year></date></history><permissions><copyright-statement>Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.</copyright-statement><copyright-year>2016</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc-nd/4.0">http://creativecommons.org/licenses/by-nc-nd/4.0</ext-link></license-p></license></permissions><self-uri xlink:type="simple" xlink:href="aids-30-635.pdf"></self-uri><abstract><sec sec-type="intro"><title>Introduction:</title><p>Previous unblinded trials have shown increased malaria among HIV-infected adults on antiretroviral therapy (ART) who stop cotrimoxazole (CTX) prophylaxis. We investigated the effect of stopping CTX on malaria in HIV-infected adults on ART in a double-blind, placebo-controlled trial.</p></sec><sec sec-type="methods"><title>Methods:</title><p>HIV-infected Ugandan adults stable on ART and CTX with CD4<sup>+</sup> cell count at least 250 cells/μl were randomized (1 : 1) to continue CTX or stop CTX and receive matching placebo (COSTOP trial; ISRCTN44723643). Clinical malaria was defined as fever and a positive blood slide, and considered severe if a participant had at least one clinical or laboratory feature of severity or was admitted to hospital. Malaria incidence and rate ratios were estimated using random effects Poisson regression, accounting for multiple episodes.</p></sec><sec sec-type="results"><title>Results:</title><p>A total of 2180 participants were enrolled and followed for a median of 2.5 years; 453 malaria episodes were recorded. Malaria incidence was 9.1/100 person-years (pyrs) [95% confidence interval (CI) = 8.2–10.1] and was higher on placebo (rate ratio 3.47; CI = 2.74–4.39). Malaria in the placebo arm decreased over time; although incidence remained higher than in the CTX arm, the difference between arms reduced slightly (interaction <italic>P</italic> value = 0.10). Fifteen participants experienced severe malaria (<1%); overall incidence was 0.30/100 pyrs (CI = 0.18–0.49). There was one malaria-related death (CTX arm).</p></sec><sec sec-type="conclusion"><title>Conclusion:</title><p>HIV-infected adults – who are stable on ART and stop prophylactic CTX – experience more malaria than those that continue, but this difference is less than has been reported in previous trials. Few participants had severe malaria. Further research might be useful in identifying groups that can safely stop CTX prophylaxis.</p></sec></abstract><kwd-group><title>Keywords</title><kwd>antiretroviral therapy</kwd><kwd>cotrimoxazole</kwd><kwd>HIV</kwd><kwd>malaria</kwd><kwd>trimethoprim/sulfamethoxazole</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>OPEN-ACCESS</meta-name><meta-value>TRUE</meta-value></custom-meta></custom-meta-group></article-meta></front><floats-group><table-wrap id="T1" position="float"><label>Table 1</label><caption><p>Baseline characteristics by trial arm and site.</p></caption><table frame="hsides" rules="groups"><thead><tr><td rowspan="1" colspan="1"></td><td colspan="2" rowspan="1">Overall (<italic>N</italic> = 2180)</td><td colspan="6" rowspan="1">Site</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td colspan="3" rowspan="1">Entebbe</td><td colspan="3" rowspan="1">Masaka</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">CTX (<italic>N</italic> = 1089)</td><td rowspan="1" colspan="1">Placebo (<italic>N</italic> = 1091)</td><td rowspan="1" colspan="1">CTX (<italic>N</italic> = 501)</td><td rowspan="1" colspan="1">Placebo (<italic>N</italic> = 501)</td><td rowspan="1" colspan="1">Total (<italic>N</italic> = 1002)</td><td rowspan="1" colspan="1">CTX (<italic>N</italic> = 588)</td><td rowspan="1" colspan="1">Placebo (<italic>N</italic> = 590)</td><td rowspan="1" colspan="1">Total (<italic>N</italic> = 1178)</td></tr></thead><tbody><tr><td rowspan="1" colspan="1">Age</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"><italic>P</italic> = 0.002<xref ref-type="table-fn" rid="TF1-1"><sup>a</sup></xref></td></tr><tr><td rowspan="1" colspan="1"> <30</td><td rowspan="1" colspan="1">85 (7.8)</td><td rowspan="1" colspan="1">83 (7.6)</td><td rowspan="1" colspan="1">47 (9.4)</td><td rowspan="1" colspan="1">38 (7.6)</td><td rowspan="1" colspan="1">85 (8.4)</td><td rowspan="1" colspan="1">38 (6.5)</td><td rowspan="1" colspan="1">45 (7.6)</td><td rowspan="1" colspan="1">83 (7.0)</td></tr><tr><td rowspan="1" colspan="1"> 30–34</td><td rowspan="1" colspan="1">148 (13.6)</td><td rowspan="1" colspan="1">189 (17.3)</td><td rowspan="1" colspan="1">75 (15.0)</td><td rowspan="1" colspan="1">104 (20.8)</td><td rowspan="1" colspan="1">179 (17.9)</td><td rowspan="1" colspan="1">73 (12.4)</td><td rowspan="1" colspan="1">85 (14.4)</td><td rowspan="1" colspan="1">158 (13.4)</td></tr><tr><td rowspan="1" colspan="1"> 35–39</td><td rowspan="1" colspan="1">232 (21.3)</td><td rowspan="1" colspan="1">235 (21.5)</td><td rowspan="1" colspan="1">112 (22.3)</td><td rowspan="1" colspan="1">107 (21.3)</td><td rowspan="1" colspan="1">219 (21.9)</td><td rowspan="1" colspan="1">120 (20.4)</td><td rowspan="1" colspan="1">128 (21.7)</td><td rowspan="1" colspan="1">248 (21.1)</td></tr><tr><td rowspan="1" colspan="1"> 40–44</td><td rowspan="1" colspan="1">262 (24.1)</td><td rowspan="1" colspan="1">221 (20.3)</td><td rowspan="1" colspan="1">116 (23.1)</td><td rowspan="1" colspan="1">100 (20.0)</td><td rowspan="1" colspan="1">216 (21.6)</td><td rowspan="1" colspan="1">146 (24.8)</td><td rowspan="1" colspan="1">121 (20.5)</td><td rowspan="1" colspan="1">267 (22.7)</td></tr><tr><td rowspan="1" colspan="1"> 45–49</td><td rowspan="1" colspan="1">198 (18.2)</td><td rowspan="1" colspan="1">190 (17.4)</td><td rowspan="1" colspan="1">87 (17.4)</td><td rowspan="1" colspan="1">91 (18.1)</td><td rowspan="1" colspan="1">178 (17.8)</td><td rowspan="1" colspan="1">111 (18.9)</td><td rowspan="1" colspan="1">99 (16.8)</td><td rowspan="1" colspan="1">210 (17.8)</td></tr><tr><td rowspan="1" colspan="1"> ≥50</td><td rowspan="1" colspan="1">164 (15.1)</td><td rowspan="1" colspan="1">173 (15.9)</td><td rowspan="1" colspan="1">64 (12.8)</td><td rowspan="1" colspan="1">61 (12.2)</td><td rowspan="1" colspan="1">125 (12.4)</td><td rowspan="1" colspan="1">100 (17.0)</td><td rowspan="1" colspan="1">112 (19.0)</td><td rowspan="1" colspan="1">212 (18.0)</td></tr><tr><td rowspan="1" colspan="1">Mean age (SD)</td><td rowspan="1" colspan="1">41.0 (8.0)</td><td rowspan="1" colspan="1">40.7 (8.3)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">40.0 (8.0)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">41.5 (8.3)</td></tr><tr><td rowspan="1" colspan="1">CD4<sup>+</sup> cell count stratum</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"><italic>P</italic> = 0.001</td></tr><tr><td rowspan="1" colspan="1"> 250–<500 cells/μl</td><td rowspan="1" colspan="1">563 (56.2)</td><td rowspan="1" colspan="1">577 (49.0)</td><td rowspan="1" colspan="1">282 (56.3)</td><td rowspan="1" colspan="1">281 (56.1)</td><td rowspan="1" colspan="1">563 (56.2)</td><td rowspan="1" colspan="1">288 (49.0)</td><td rowspan="1" colspan="1">289 (49.0)</td><td rowspan="1" colspan="1">577 (49.0)</td></tr><tr><td rowspan="1" colspan="1"> ≥500 cells/μl</td><td rowspan="1" colspan="1">439 (43.8)</td><td rowspan="1" colspan="1">601 (51.0)</td><td rowspan="1" colspan="1">219 (43.7)</td><td rowspan="1" colspan="1">220 (43.9)</td><td rowspan="1" colspan="1">439 (43.8)</td><td rowspan="1" colspan="1">300 (51.0)</td><td rowspan="1" colspan="1">301 (51.0)</td><td rowspan="1" colspan="1">601 (51.0)</td></tr><tr><td rowspan="1" colspan="1">Time on ART (years)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"><italic>P</italic> < 0.001</td></tr><tr><td rowspan="1" colspan="1"> <1</td><td rowspan="1" colspan="1">73 (6.7)</td><td rowspan="1" colspan="1">82 (7.5)</td><td rowspan="1" colspan="1">46 (9.2)</td><td rowspan="1" colspan="1">43 (8.6)</td><td rowspan="1" colspan="1">89 (8.9)</td><td rowspan="1" colspan="1">27 (4.6)</td><td rowspan="1" colspan="1">39 (6.6)</td><td rowspan="1" colspan="1">66 (5.6)</td></tr><tr><td rowspan="1" colspan="1"> 1–2</td><td rowspan="1" colspan="1">144 (13.2)</td><td rowspan="1" colspan="1">160 (14.7)</td><td rowspan="1" colspan="1">71 (14.2)</td><td rowspan="1" colspan="1">79 (15.8)</td><td rowspan="1" colspan="1">150 (15.0)</td><td rowspan="1" colspan="1">73 (12.4)</td><td rowspan="1" colspan="1">81 (13.7)</td><td rowspan="1" colspan="1">154 (13.1)</td></tr><tr><td rowspan="1" colspan="1"> 2–5</td><td rowspan="1" colspan="1">508 (46.7)</td><td rowspan="1" colspan="1">480 (44.0)</td><td rowspan="1" colspan="1">261 (52.0)</td><td rowspan="1" colspan="1">255 (50.9)</td><td rowspan="1" colspan="1">516 (51.5)</td><td rowspan="1" colspan="1">247 (42.0)</td><td rowspan="1" colspan="1">225 (38.2)</td><td rowspan="1" colspan="1">472 (40.1)</td></tr><tr><td rowspan="1" colspan="1"> >5</td><td rowspan="1" colspan="1">364 (33.4)</td><td rowspan="1" colspan="1">369 (33.8)</td><td rowspan="1" colspan="1">123 (24.6)</td><td rowspan="1" colspan="1">124 (24.7)</td><td rowspan="1" colspan="1">247 (24.6)</td><td rowspan="1" colspan="1">241 (41.0)</td><td rowspan="1" colspan="1">245 (41.5)</td><td rowspan="1" colspan="1">486 (41.3)</td></tr><tr><td rowspan="1" colspan="1">Sex</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"><italic>P</italic> = 0.520</td></tr><tr><td rowspan="1" colspan="1"> Man</td><td rowspan="1" colspan="1">286 (26.3)</td><td rowspan="1" colspan="1">283 (25.9)</td><td rowspan="1" colspan="1">130 (26.0)</td><td rowspan="1" colspan="1">125 (25.0)</td><td rowspan="1" colspan="1">255 (25.5)</td><td rowspan="1" colspan="1">156 (26.5)</td><td rowspan="1" colspan="1">158 (26.8)</td><td rowspan="1" colspan="1">314 (26.7)</td></tr><tr><td rowspan="1" colspan="1"> Women</td><td rowspan="1" colspan="1">803 (73.7)</td><td rowspan="1" colspan="1">808 (74.1)</td><td rowspan="1" colspan="1">371 (74.0)</td><td rowspan="1" colspan="1">376 (75.0)</td><td rowspan="1" colspan="1">747 (74.6)</td><td rowspan="1" colspan="1">432 (73.5)</td><td rowspan="1" colspan="1">432 (73.2)</td><td rowspan="1" colspan="1">864 (73.3)</td></tr><tr><td rowspan="1" colspan="1">Education level</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"><italic>P</italic> < 0.001</td></tr><tr><td rowspan="1" colspan="1"> None</td><td rowspan="1" colspan="1">111 (10.2)</td><td rowspan="1" colspan="1">113 (10.4)</td><td rowspan="1" colspan="1">46 (9.2)</td><td rowspan="1" colspan="1">37 (7.4)</td><td rowspan="1" colspan="1">83 (8.3)</td><td rowspan="1" colspan="1">65 (11.2)</td><td rowspan="1" colspan="1">76 (12.9)</td><td rowspan="1" colspan="1">141 (11.9)</td></tr><tr><td rowspan="1" colspan="1"> Primary</td><td rowspan="1" colspan="1">649 (59.6)</td><td rowspan="1" colspan="1">660 (60.5)</td><td rowspan="1" colspan="1">259 (51.7)</td><td rowspan="1" colspan="1">281 (56.1)</td><td rowspan="1" colspan="1">540 (53.9)</td><td rowspan="1" colspan="1">390 (66.3)</td><td rowspan="1" colspan="1">379 (64.2)</td><td rowspan="1" colspan="1">769 (65.3)</td></tr><tr><td rowspan="1" colspan="1"> Secondary</td><td rowspan="1" colspan="1">276 (25.3)</td><td rowspan="1" colspan="1">268 (24.6)</td><td rowspan="1" colspan="1">160 (31.9)</td><td rowspan="1" colspan="1">157 (31.3)</td><td rowspan="1" colspan="1">317 (31.6)</td><td rowspan="1" colspan="1">116 (19.7)</td><td rowspan="1" colspan="1">111 (18.8)</td><td rowspan="1" colspan="1">227 (19.3)</td></tr><tr><td rowspan="1" colspan="1"> Tertiary</td><td rowspan="1" colspan="1">53 (4.9)</td><td rowspan="1" colspan="1">50 (4.6)</td><td rowspan="1" colspan="1">36 (7.2)</td><td rowspan="1" colspan="1">26 (5.2)</td><td rowspan="1" colspan="1">62 (6.2)</td><td rowspan="1" colspan="1">17 (2.8)</td><td rowspan="1" colspan="1">24 (4.1)</td><td rowspan="1" colspan="1">41 (3.5)</td></tr><tr><td rowspan="1" colspan="1">Socio-economic status</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"><italic>P</italic> < 0.001</td></tr><tr><td rowspan="1" colspan="1"> Low</td><td rowspan="1" colspan="1">486 (44.6)</td><td rowspan="1" colspan="1">474 (43.4)</td><td rowspan="1" colspan="1">197 (39.3)</td><td rowspan="1" colspan="1">213 (42.5)</td><td rowspan="1" colspan="1">410 (40.9)</td><td rowspan="1" colspan="1">289 (49.1)</td><td rowspan="1" colspan="1">261 (44.2)</td><td rowspan="1" colspan="1">550 (46.7)</td></tr><tr><td rowspan="1" colspan="1"> Medium</td><td rowspan="1" colspan="1">318 (29.2)</td><td rowspan="1" colspan="1">329 (30.2)</td><td rowspan="1" colspan="1">117 (23.4)</td><td rowspan="1" colspan="1">113 (22.6)</td><td rowspan="1" colspan="1">230 (23.0)</td><td rowspan="1" colspan="1">201 (34.2)</td><td rowspan="1" colspan="1">216 (36.6)</td><td rowspan="1" colspan="1">417 (35.4)</td></tr><tr><td rowspan="1" colspan="1"> High</td><td rowspan="1" colspan="1">285 (26.2)</td><td rowspan="1" colspan="1">288 (26.4)</td><td rowspan="1" colspan="1">187 (37.3)</td><td rowspan="1" colspan="1">175 (33.9)</td><td rowspan="1" colspan="1">362 (36.1)</td><td rowspan="1" colspan="1">98 (16.7)</td><td rowspan="1" colspan="1">113 (19.2)</td><td rowspan="1" colspan="1">211 (17.9)</td></tr><tr><td rowspan="1" colspan="1">Marital status</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"><italic>P</italic> = 0.32</td></tr><tr><td rowspan="1" colspan="1"> Married/cohabiting</td><td rowspan="1" colspan="1">473 (43.4)</td><td rowspan="1" colspan="1">465 (42.6)</td><td rowspan="1" colspan="1">213 (42.5)</td><td rowspan="1" colspan="1">210 (41.9)</td><td rowspan="1" colspan="1">423 (42.2)</td><td rowspan="1" colspan="1">260 (44.2)</td><td rowspan="1" colspan="1">255 (43.2)</td><td rowspan="1" colspan="1">515 (43.7)</td></tr><tr><td rowspan="1" colspan="1"> Divorced/separated/widowed</td><td rowspan="1" colspan="1">577 (53.0)</td><td rowspan="1" colspan="1">577 (52.9)</td><td rowspan="1" colspan="1">271 (54.1)</td><td rowspan="1" colspan="1">273 (54.5)</td><td rowspan="1" colspan="1">544 (54.3)</td><td rowspan="1" colspan="1">306 (52.0)</td><td rowspan="1" colspan="1">304 (51.3)</td><td rowspan="1" colspan="1">610 (51.8)</td></tr><tr><td rowspan="1" colspan="1"> Single</td><td rowspan="1" colspan="1">39 (3.6)</td><td rowspan="1" colspan="1">49 (4.5)</td><td rowspan="1" colspan="1">17 (3.4)</td><td rowspan="1" colspan="1">18 (3.6)</td><td rowspan="1" colspan="1">35 (3.5)</td><td rowspan="1" colspan="1">22 (3.7)</td><td rowspan="1" colspan="1">31 (5.3)</td><td rowspan="1" colspan="1">53 (4.5)</td></tr></tbody></table><table-wrap-foot><fn fn-type="other"><p>ART, antiretroviral therapy; CTX, cotrimoxazole.</p></fn><fn fn-type="other" id="TF1-1"><p><sup>a</sup><italic>P</italic> value for comparison between sites, by χ<sup>2</sup> test.</p></fn></table-wrap-foot></table-wrap><table-wrap id="T2" position="float"><label>Table 2</label><caption><p>Incidence of malaria by trial arm, follow-up time, trial site, adherence to trial drug and ITN use.</p></caption><table frame="hsides" rules="groups"><thead><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Trial arm</td><td rowspan="1" colspan="1">Episodes</td><td rowspan="1" colspan="1">Person-years</td><td rowspan="1" colspan="1">Rate/100 person-years (95% CI)<xref ref-type="table-fn" rid="TF2-1"><sup>a</sup></xref></td><td rowspan="1" colspan="1">Rate ratio<xref ref-type="table-fn" rid="TF2-1"><sup>a</sup></xref></td><td rowspan="1" colspan="1"><italic>P</italic> value (CTX vs. placebo)</td><td rowspan="1" colspan="1"><italic>P</italic> value (for interaction)<xref ref-type="table-fn" rid="TF2-2"><sup>b</sup></xref></td></tr></thead><tbody><tr><td colspan="8" rowspan="1">Clinical malaria</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">103</td><td rowspan="1" colspan="1">2540</td><td rowspan="1" colspan="1">4.1 (3.3–5.0)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1"><0.001</td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">350</td><td rowspan="1" colspan="1">2515</td><td rowspan="1" colspan="1">14.1 (12.5–15.0)</td><td rowspan="1" colspan="1">3.5 (2.5–4.4)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td colspan="8" rowspan="1">Severe malaria<xref ref-type="table-fn" rid="TF2-3"><sup>c</sup></xref><sup>,</sup><xref ref-type="table-fn" rid="TF2-4"><sup>d</sup></xref></td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">2543</td><td rowspan="1" colspan="1">0.08 (0.02–0.31)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">0.004</td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">13</td><td rowspan="1" colspan="1">2524</td><td rowspan="1" colspan="1">0.52 (0.30–0.89)</td><td rowspan="1" colspan="1">6.55 (1.48–29.01)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td colspan="8" rowspan="1">Stratified analyses</td></tr><tr><td colspan="8" rowspan="1">Stratum variable</td></tr><tr><td colspan="8" rowspan="1">Follow-up time</td></tr><tr><td rowspan="1" colspan="1">1st year</td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">51</td><td rowspan="1" colspan="1">1065</td><td rowspan="1" colspan="1">4.8 (3.6–6.3)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1"><0.001</td><td rowspan="1" colspan="1">0.097</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">183</td><td rowspan="1" colspan="1">1062</td><td rowspan="1" colspan="1">17.3 (14.8–20.2)</td><td rowspan="1" colspan="1">3.6 (2.6–5.0)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1">2nd year</td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">29</td><td rowspan="1" colspan="1">939</td><td rowspan="1" colspan="1">3.1 (2.1–4.5)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1"><0.001</td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">120</td><td rowspan="1" colspan="1">924</td><td rowspan="1" colspan="1">13.1 (10.8–15.8)</td><td rowspan="1" colspan="1">4.2 (2.8–6.4)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1">After 2nd year</td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">23</td><td rowspan="1" colspan="1">536</td><td rowspan="1" colspan="1">4.3 (2.8–6.5)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">0.004</td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">47</td><td rowspan="1" colspan="1">528</td><td rowspan="1" colspan="1">9.0 (6.7–12.1)</td><td rowspan="1" colspan="1">2.1 (1.3–3.5)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td colspan="8" rowspan="1">Site</td></tr><tr><td rowspan="1" colspan="1">Entebbe</td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">19</td><td rowspan="1" colspan="1">1215</td><td rowspan="1" colspan="1">1.6 (1.0–2.5)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1"><0.001</td><td rowspan="1" colspan="1"><0.001</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">127</td><td rowspan="1" colspan="1">1209</td><td rowspan="1" colspan="1">10.6 (8.8–12.8)</td><td rowspan="1" colspan="1">6.8 (4.1–11.1)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1">Masaka</td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">84</td><td rowspan="1" colspan="1">1325</td><td rowspan="1" colspan="1">6.3 (5.1–7.9)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1"><0.001</td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">223</td><td rowspan="1" colspan="1">1306</td><td rowspan="1" colspan="1">17.2 (14.8–20.0)</td><td rowspan="1" colspan="1">2.7 (2.1–3.6)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td colspan="8" rowspan="1">Trial drug adherence</td></tr><tr><td colspan="8" rowspan="1">Good adherence at</td></tr><tr><td rowspan="1" colspan="1"> ≥80% of visits<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref><sup>,</sup><xref ref-type="table-fn" rid="TF2-6"><sup>f</sup></xref></td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">57</td><td rowspan="1" colspan="1">1724</td><td rowspan="1" colspan="1">3.3 (2.5–4.4)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">0.01</td><td rowspan="1" colspan="1">0.25</td></tr><tr><td rowspan="1" colspan="1"> <80% of visits<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref><sup>,</sup><xref ref-type="table-fn" rid="TF2-6"><sup>f</sup></xref></td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">46</td><td rowspan="1" colspan="1">816</td><td rowspan="1" colspan="1">5.6 (4.1–7.6)</td><td rowspan="1" colspan="1">1.7 (1.1–2.6)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"> ≥80% of visits<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref><sup>,</sup><xref ref-type="table-fn" rid="TF2-7"><sup>g</sup></xref></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">205</td><td rowspan="1" colspan="1">1617</td><td rowspan="1" colspan="1">12.8 (12.0–14.9)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">0.05</td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"> <80% of visits<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref><sup>,</sup><xref ref-type="table-fn" rid="TF2-7"><sup>g</sup></xref></td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">145</td><td rowspan="1" colspan="1">897</td><td rowspan="1" colspan="1">16.4 (13.6–19.8)</td><td rowspan="1" colspan="1">1.3 (1.0–1.6)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td colspan="8" rowspan="1">ITN use</td></tr><tr><td colspan="8" rowspan="1">Reported always using ITN at</td></tr><tr><td rowspan="1" colspan="1"> ≥90% of visits</td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">86</td><td rowspan="1" colspan="1">2124</td><td rowspan="1" colspan="1">4.1 (3.3–5.1)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1"><italic>P</italic> = 0.98</td><td rowspan="1" colspan="1">0.39</td></tr><tr><td rowspan="1" colspan="1"> <90% off visits</td><td rowspan="1" colspan="1">CTX</td><td rowspan="1" colspan="1">17</td><td rowspan="1" colspan="1">416</td><td rowspan="1" colspan="1">4.1 (2.5–6.7)</td><td rowspan="1" colspan="1">1.0 (0.6–1.7)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"> ≥90% of visits</td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">267</td><td rowspan="1" colspan="1">2038</td><td rowspan="1" colspan="1">13.3 (11.6–15.2)</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1"><italic>P</italic> = 0.06</td><td rowspan="1" colspan="1"></td></tr><tr><td rowspan="1" colspan="1"> <90% off visits</td><td rowspan="1" colspan="1">Placebo</td><td rowspan="1" colspan="1">83</td><td rowspan="1" colspan="1">476</td><td rowspan="1" colspan="1">17.5 (13.6–22.5)</td><td rowspan="1" colspan="1">1.3 (1.0–1.8)</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr></tbody></table><table-wrap-foot><fn fn-type="other"><p>CTX, cotrimoxazole; ITN, insecticide-treated bed net.</p></fn><fn fn-type="other" id="TF2-1"><p><sup>a</sup>rates and rate ratios adjusted for clustering of multiple episodes within participant using random effects Poisson regression.</p></fn><fn fn-type="other" id="TF2-2"><p><sup>b</sup><italic>P</italic> value for interaction between stratum variable with treatment arm.</p></fn><fn fn-type="other" id="TF2-3"><p><sup>c</sup><italic>P. falciparum</italic> malaria with clinical or laboratory features of severity.</p></fn><fn fn-type="other" id="TF2-4"><p><sup>d</sup>Rates and rate ratios from Poisson regression without adjustment for clustering since no participant had more than one episode.</p></fn><fn fn-type="other" id="TF2-5"><p><sup>e</sup>‘Good’ adherence defined as 80–105% of expected tablets taken, based on pill counts.</p></fn><fn fn-type="other" id="TF2-6"><p><sup>f</sup>Rate ratio and <italic>P</italic> value for comparison in CTX arm.</p></fn><fn fn-type="other" id="TF2-7"><p><sup>g</sup>Rate ratio and <italic>P</italic> value for comparison in placebo arm.</p></fn></table-wrap-foot></table-wrap></floats-group></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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