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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Timing of Antiretroviral Therapy after Diagnosis of Cryptococcal Meningitis</title><author><name sortKey="Boulware, David R" sort="Boulware, David R" uniqKey="Boulware D" first="David R." last="Boulware">David R. Boulware</name></author><author><name sortKey="Meya, David B" sort="Meya, David B" uniqKey="Meya D" first="David B." last="Meya">David B. Meya</name></author><author><name sortKey="Muzoora, Conrad" sort="Muzoora, Conrad" uniqKey="Muzoora C" first="Conrad" last="Muzoora">Conrad Muzoora</name></author><author><name sortKey="Rolfes, Melissa A" sort="Rolfes, Melissa A" uniqKey="Rolfes M" first="Melissa A." last="Rolfes">Melissa A. Rolfes</name></author><author><name sortKey="Huppler Hullsiek, Katherine" sort="Huppler Hullsiek, Katherine" uniqKey="Huppler Hullsiek K" first="Katherine" last="Huppler Hullsiek">Katherine Huppler Hullsiek</name></author><author><name sortKey="Musubire, Abdu" sort="Musubire, Abdu" uniqKey="Musubire A" first="Abdu" last="Musubire">Abdu Musubire</name></author><author><name sortKey="Taseera, Kabanda" sort="Taseera, Kabanda" uniqKey="Taseera K" first="Kabanda" last="Taseera">Kabanda Taseera</name></author><author><name sortKey="Nabeta, Henry W" sort="Nabeta, Henry W" uniqKey="Nabeta H" first="Henry W." last="Nabeta">Henry W. Nabeta</name></author><author><name sortKey="Schutz, Charlotte" sort="Schutz, Charlotte" uniqKey="Schutz C" first="Charlotte" last="Schutz">Charlotte Schutz</name></author><author><name sortKey="Williams, Darlisha A" sort="Williams, Darlisha A" uniqKey="Williams D" first="Darlisha A." last="Williams">Darlisha A. Williams</name></author><author><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name></author><author><name sortKey="Rhein, Joshua" sort="Rhein, Joshua" uniqKey="Rhein J" first="Joshua" last="Rhein">Joshua Rhein</name></author><author><name sortKey="Thienemann, Friedrich" sort="Thienemann, Friedrich" uniqKey="Thienemann F" first="Friedrich" last="Thienemann">Friedrich Thienemann</name></author><author><name sortKey="Lo, Melanie W" sort="Lo, Melanie W" uniqKey="Lo M" first="Melanie W." last="Lo">Melanie W. Lo</name></author><author><name sortKey="Nielsen, Kirsten" sort="Nielsen, Kirsten" uniqKey="Nielsen K" first="Kirsten" last="Nielsen">Kirsten Nielsen</name></author><author><name sortKey="Bergemann, Tracy L" sort="Bergemann, Tracy L" uniqKey="Bergemann T" first="Tracy L." last="Bergemann">Tracy L. Bergemann</name></author><author><name sortKey="Kambugu, Andrew" sort="Kambugu, Andrew" uniqKey="Kambugu A" first="Andrew" last="Kambugu">Andrew Kambugu</name></author><author><name sortKey="Manabe, Yukari C" sort="Manabe, Yukari C" uniqKey="Manabe Y" first="Yukari C." last="Manabe">Yukari C. Manabe</name></author><author><name sortKey="Janoff, Edward N" sort="Janoff, Edward N" uniqKey="Janoff E" first="Edward N." last="Janoff">Edward N. Janoff</name></author><author><name sortKey="Bohjanen, Paul R" sort="Bohjanen, Paul R" uniqKey="Bohjanen P" first="Paul R." last="Bohjanen">Paul R. Bohjanen</name></author><author><name sortKey="Meintjes, Graeme" sort="Meintjes, Graeme" uniqKey="Meintjes G" first="Graeme" last="Meintjes">Graeme Meintjes</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24963568</idno><idno type="pmc">4127879</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4127879</idno><idno type="RBID">PMC:4127879</idno><idno type="doi">10.1056/NEJMoa1312884</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000421</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Timing of Antiretroviral Therapy after Diagnosis of Cryptococcal Meningitis</title><author><name sortKey="Boulware, David R" sort="Boulware, David R" uniqKey="Boulware D" first="David R." last="Boulware">David R. Boulware</name></author><author><name sortKey="Meya, David B" sort="Meya, David B" uniqKey="Meya D" first="David B." last="Meya">David B. Meya</name></author><author><name sortKey="Muzoora, Conrad" sort="Muzoora, Conrad" uniqKey="Muzoora C" first="Conrad" last="Muzoora">Conrad Muzoora</name></author><author><name sortKey="Rolfes, Melissa A" sort="Rolfes, Melissa A" uniqKey="Rolfes M" first="Melissa A." last="Rolfes">Melissa A. Rolfes</name></author><author><name sortKey="Huppler Hullsiek, Katherine" sort="Huppler Hullsiek, Katherine" uniqKey="Huppler Hullsiek K" first="Katherine" last="Huppler Hullsiek">Katherine Huppler Hullsiek</name></author><author><name sortKey="Musubire, Abdu" sort="Musubire, Abdu" uniqKey="Musubire A" first="Abdu" last="Musubire">Abdu Musubire</name></author><author><name sortKey="Taseera, Kabanda" sort="Taseera, Kabanda" uniqKey="Taseera K" first="Kabanda" last="Taseera">Kabanda Taseera</name></author><author><name sortKey="Nabeta, Henry W" sort="Nabeta, Henry W" uniqKey="Nabeta H" first="Henry W." last="Nabeta">Henry W. Nabeta</name></author><author><name sortKey="Schutz, Charlotte" sort="Schutz, Charlotte" uniqKey="Schutz C" first="Charlotte" last="Schutz">Charlotte Schutz</name></author><author><name sortKey="Williams, Darlisha A" sort="Williams, Darlisha A" uniqKey="Williams D" first="Darlisha A." last="Williams">Darlisha A. Williams</name></author><author><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name></author><author><name sortKey="Rhein, Joshua" sort="Rhein, Joshua" uniqKey="Rhein J" first="Joshua" last="Rhein">Joshua Rhein</name></author><author><name sortKey="Thienemann, Friedrich" sort="Thienemann, Friedrich" uniqKey="Thienemann F" first="Friedrich" last="Thienemann">Friedrich Thienemann</name></author><author><name sortKey="Lo, Melanie W" sort="Lo, Melanie W" uniqKey="Lo M" first="Melanie W." last="Lo">Melanie W. Lo</name></author><author><name sortKey="Nielsen, Kirsten" sort="Nielsen, Kirsten" uniqKey="Nielsen K" first="Kirsten" last="Nielsen">Kirsten Nielsen</name></author><author><name sortKey="Bergemann, Tracy L" sort="Bergemann, Tracy L" uniqKey="Bergemann T" first="Tracy L." last="Bergemann">Tracy L. Bergemann</name></author><author><name sortKey="Kambugu, Andrew" sort="Kambugu, Andrew" uniqKey="Kambugu A" first="Andrew" last="Kambugu">Andrew Kambugu</name></author><author><name sortKey="Manabe, Yukari C" sort="Manabe, Yukari C" uniqKey="Manabe Y" first="Yukari C." last="Manabe">Yukari C. Manabe</name></author><author><name sortKey="Janoff, Edward N" sort="Janoff, Edward N" uniqKey="Janoff E" first="Edward N." last="Janoff">Edward N. Janoff</name></author><author><name sortKey="Bohjanen, Paul R" sort="Bohjanen, Paul R" uniqKey="Bohjanen P" first="Paul R." last="Bohjanen">Paul R. Bohjanen</name></author><author><name sortKey="Meintjes, Graeme" sort="Meintjes, Graeme" uniqKey="Meintjes G" first="Graeme" last="Meintjes">Graeme Meintjes</name></author></analytic><series><title level="j">The New England journal of medicine</title><idno type="ISSN">0028-4793</idno><idno type="eISSN">1533-4406</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">Cryptococcal meningitis accounts for 20 to 25% of acquired immunodeficiency syndrome–related deaths in Africa. Antiretroviral therapy (ART) is essential for survival; however, the question of when ART should be initiated after diagnosis of cryptococcal meningitis remains unanswered.</p></sec><sec id="S2"><title>Methods</title><p id="P2">We assessed survival at 26 weeks among 177 human immunodeficiency virus–infected adults in Uganda and South Africa who had cryptococcal meningitis and had not previously received ART. We randomly assigned study participants to undergo either earlier ART initiation (1 to 2 weeks after diagnosis) or deferred ART initiation (5 weeks after diagnosis). Participants received amphotericin B (0.7 to 1.0 mg per kilogram of body weight per day) and fluconazole (800 mg per day) for 14 days, followed by consolidation therapy with fluconazole.</p></sec><sec id="S3"><title>Results</title><p id="P3">The 26-week mortality with earlier ART initiation was significantly higher than with deferred ART initiation (45% [40 of 88 patients] vs. 30% [27 of 89 patients]; hazard ratio for death, 1.73; 95% confidence interval [CI], 1.06 to 2.82; P = 0.03). The excess deaths associated with earlier ART initiation occurred 2 to 5 weeks after diagnosis (P = 0.007 for the comparison between groups); mortality was similar in the two groups thereafter. Among patients with few white cells in their cerebrospinal fluid (<5 per cubic millimeter) at randomization, mortality was particularly elevated with earlier ART as compared with deferred ART (hazard ratio, 3.87; 95% CI, 1.41 to 10.58; P = 0.008). The incidence of recognized cryptococcal immune reconstitution inflammatory syndrome did not differ significantly between the earlier-ART group and the deferred-ART group (20% and 13%, respectively; P = 0.32). All other clinical, immunologic, virologic, and microbiologic outcomes, as well as adverse events, were similar between the groups.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">Deferring ART for 5 weeks after the diagnosis of cryptococcal meningitis was associated with significantly improved survival, as compared with initiating ART at 1 to 2 weeks, especially among patients with a paucity of white cells in cerebrospinal fluid. (Funded by the National Institute of Allergy and Infectious Diseases and others; COAT <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> number, NCT01075152.)</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
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<front><journal-meta><journal-id journal-id-type="nlm-journal-id">0255562</journal-id><journal-id journal-id-type="pubmed-jr-id">5985</journal-id><journal-id journal-id-type="nlm-ta">N Engl J Med</journal-id><journal-id journal-id-type="iso-abbrev">N. Engl. J. Med.</journal-id><journal-title-group><journal-title>The New England journal of medicine</journal-title></journal-title-group><issn pub-type="ppub">0028-4793</issn><issn pub-type="epub">1533-4406</issn></journal-meta><article-meta><article-id pub-id-type="pmid">24963568</article-id><article-id pub-id-type="pmc">4127879</article-id><article-id pub-id-type="doi">10.1056/NEJMoa1312884</article-id><article-id pub-id-type="manuscript">NIHMS610509</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Timing of Antiretroviral Therapy after Diagnosis of Cryptococcal Meningitis</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Boulware</surname><given-names>David R.</given-names></name><degrees>M.D., M.P.H.</degrees></contrib><contrib contrib-type="author"><name><surname>Meya</surname><given-names>David B.</given-names></name><degrees>M.Med.</degrees></contrib><contrib contrib-type="author"><name><surname>Muzoora</surname><given-names>Conrad</given-names></name><degrees>M. Med.</degrees></contrib><contrib contrib-type="author"><name><surname>Rolfes</surname><given-names>Melissa A.</given-names></name><degrees>Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Huppler Hullsiek</surname><given-names>Katherine</given-names></name><degrees>Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Musubire</surname><given-names>Abdu</given-names></name><degrees>M.Med.</degrees></contrib><contrib contrib-type="author"><name><surname>Taseera</surname><given-names>Kabanda</given-names></name><degrees>M.Med.</degrees></contrib><contrib contrib-type="author"><name><surname>Nabeta</surname><given-names>Henry W.</given-names></name><degrees>M.B., Ch.B.</degrees></contrib><contrib contrib-type="author"><name><surname>Schutz</surname><given-names>Charlotte</given-names></name><degrees>M.B., Ch.B., M.P.H.</degrees></contrib><contrib contrib-type="author"><name><surname>Williams</surname><given-names>Darlisha A.</given-names></name><degrees>M.P.H.</degrees></contrib><contrib contrib-type="author"><name><surname>Rajasingham</surname><given-names>Radha</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Rhein</surname><given-names>Joshua</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Thienemann</surname><given-names>Friedrich</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Lo</surname><given-names>Melanie W.</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Nielsen</surname><given-names>Kirsten</given-names></name><degrees>Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Bergemann</surname><given-names>Tracy L.</given-names></name><degrees>Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Kambugu</surname><given-names>Andrew</given-names></name><degrees>M.Med.</degrees></contrib><contrib contrib-type="author"><name><surname>Manabe</surname><given-names>Yukari C.</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Janoff</surname><given-names>Edward N.</given-names></name><degrees>M.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Bohjanen</surname><given-names>Paul R.</given-names></name><degrees>M.D., Ph.D.</degrees></contrib><contrib contrib-type="author"><name><surname>Meintjes</surname><given-names>Graeme</given-names></name><degrees>M.B., Ch.B., Ph.D.</degrees><on-behalf-of>for the COAT Trial Team</on-behalf-of><xref ref-type="fn" rid="FN1">*</xref></contrib><aff id="A1">University of Minnesota, Minneapolis (D.R.B., D.B.M., M.A.R., K.H.H., D.A.W., R.R., J.R., M.W.L., K.N., T.L.B., P.R.B.); the Infectious Disease Institute (D.B.M., A.M., H.W.N., D.A.W., R.R., J.R., M.W.L., A.K., Y.C.M.) and School of Medicine, College of Health Sciences (D.B.M.), Makerere University, Kampala, and Mbarara University of Science and Technology, Mbarara (C.M., K.T.) — both in Uganda; the University of Cape Town, Cape Town, South Africa (C.S., F.T., G.M.); Johns Hopkins School of Medicine, Baltimore ( Y.C.M.); the Mucosal and Vaccine Research Program Colorado (MAVRC), University of Colorado Denver, Aurora, and Denver Veterans Affairs Medical Center, Denver (E.N.J.); and Imperial College London, London (G.M.)</aff></contrib-group><author-notes><corresp id="cor1">Address reprint requests to Dr. Boulware at MTRF 3-222, 2001 6th St. SE, Minneapolis, MN 55455, or at <email>boulw001@umn.edu</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>2</day><month>7</month><year>2014</year></pub-date><pub-date pub-type="ppub"><day>26</day><month>6</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>26</day><month>12</month><year>2014</year></pub-date><volume>370</volume><issue>26</issue><fpage>2487</fpage><lpage>2498</lpage><pmc-comment>elocation-id from pubmed: 10.1056/NEJMoa1312884</pmc-comment>
<permissions><copyright-statement>Copyright © 2014 Massachusetts Medical Society.</copyright-statement><copyright-year>2014</copyright-year></permissions><abstract><sec id="S1"><title>Background</title><p id="P1">Cryptococcal meningitis accounts for 20 to 25% of acquired immunodeficiency syndrome–related deaths in Africa. Antiretroviral therapy (ART) is essential for survival; however, the question of when ART should be initiated after diagnosis of cryptococcal meningitis remains unanswered.</p></sec><sec id="S2"><title>Methods</title><p id="P2">We assessed survival at 26 weeks among 177 human immunodeficiency virus–infected adults in Uganda and South Africa who had cryptococcal meningitis and had not previously received ART. We randomly assigned study participants to undergo either earlier ART initiation (1 to 2 weeks after diagnosis) or deferred ART initiation (5 weeks after diagnosis). Participants received amphotericin B (0.7 to 1.0 mg per kilogram of body weight per day) and fluconazole (800 mg per day) for 14 days, followed by consolidation therapy with fluconazole.</p></sec><sec id="S3"><title>Results</title><p id="P3">The 26-week mortality with earlier ART initiation was significantly higher than with deferred ART initiation (45% [40 of 88 patients] vs. 30% [27 of 89 patients]; hazard ratio for death, 1.73; 95% confidence interval [CI], 1.06 to 2.82; P = 0.03). The excess deaths associated with earlier ART initiation occurred 2 to 5 weeks after diagnosis (P = 0.007 for the comparison between groups); mortality was similar in the two groups thereafter. Among patients with few white cells in their cerebrospinal fluid (<5 per cubic millimeter) at randomization, mortality was particularly elevated with earlier ART as compared with deferred ART (hazard ratio, 3.87; 95% CI, 1.41 to 10.58; P = 0.008). The incidence of recognized cryptococcal immune reconstitution inflammatory syndrome did not differ significantly between the earlier-ART group and the deferred-ART group (20% and 13%, respectively; P = 0.32). All other clinical, immunologic, virologic, and microbiologic outcomes, as well as adverse events, were similar between the groups.</p></sec><sec id="S4"><title>Conclusions</title><p id="P4">Deferring ART for 5 weeks after the diagnosis of cryptococcal meningitis was associated with significantly improved survival, as compared with initiating ART at 1 to 2 weeks, especially among patients with a paucity of white cells in cerebrospinal fluid. (Funded by the National Institute of Allergy and Infectious Diseases and others; COAT <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> number, NCT01075152.)</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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