{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T08:53:25Z","timestamp":1777452805513,"version":"3.51.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2014,11,1]],"date-time":"2014-11-01T00:00:00Z","timestamp":1414800000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>DRIVESHAFT is a randomized, open-label, 48-week clinical trial that examined virological outcomes and safety of antiretroviral simplification among virologically suppressed, treatment-experienced HIV-infected patients switching from darunavir\/ritonavir (DRV\/r) twice-daily-based regimens to a once-daily DRV\/r component.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>HIV-infected adults with a stable antiretroviral regimen including DRV\/r 600\/100 mg twice daily plus a minimum of two other antiretrovirals, &lt;2 historical DRV-associated mutations and HIV RNA&lt;40 copies\/ml for at least 12 weeks prior to entry were eligible. Participants were randomized 1:1 to switch DRV\/r to 800\/100 mg once daily or maintain their current regimen. The primary end point was HIV-1 RNA&lt;40 copies\/ml at week 48 using the Snapshot algorithm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Demographics and baseline characteristics were similar between arms. Virological suppression was greater in the DRV\/r once-daily ( n=30) versus twice-daily ( n=30) arm at week 48 (90.0% versus 83.3%; 95% CI: -11.5, 24.8). Three subjects discontinued the once-daily arm, with four discontinuations and one virological failure in the twice-daily arm. No discontinuations were related to adverse events. Reduction in LDL was significantly greater in the once-daily arm at week 24 (-8.0 mg\/dl versus 3.3 mg\/dl; P=0.04). There was a trend towards suboptimal adherence &lt;90% to antiretrovirals among subjects taking twice-daily versus once-daily DRV\/r by week 48 (12.0% versus 0.0%; P=0.06).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Switching from twice-daily to once-daily DRV\/r in virologically suppressed patients maintains viro-logical control, with greater reduction in LDL cholesterol by 24 weeks. This study provides pilot data that could be used to design a non-inferiority study to definitively answer the question of whether switching from twice-daily to once-daily DRV\/r maintains viral suppression. ClinicalTrials.gov number: NCT01423812.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp2962","type":"journal-article","created":{"date-parts":[[2015,4,17]],"date-time":"2015-04-17T06:23:37Z","timestamp":1429251817000},"page":"849-854","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Simplification from Twice-Daily to Once-Daily Darunavir\/Ritonavir in a Randomized Trial among HIV-Infected Persons with HIV-1 RNA Suppression on Antiretroviral Therapy"],"prefix":"10.1177","volume":"20","author":[{"given":"Gregory D","family":"Huhn","sequence":"first","affiliation":[{"name":"The Ruth M Rothstein CORE Center, Chicago, IL, USA"},{"name":"Rush University Medical Center, Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Sigman","sequence":"additional","affiliation":[{"name":"The Ruth M Rothstein CORE Center, Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Britt","family":"Livak","sequence":"additional","affiliation":[{"name":"The Ruth M Rothstein CORE Center, Chicago, IL, USA"},{"name":"University of Chicago, Chicago, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2014,11,1]]},"reference":[{"key":"bibr1-IMP2962","unstructured":"US Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. (Updated 1 May 2014. Accessed 28 September 2014.) Available from http:\/\/aidsinfo.nih.gov\/guidelines\/html\/1\/adult-and-adolescent-arv-guidelines\/0\/."},{"key":"bibr2-IMP2962","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-156-11-201206050-00419"},{"key":"bibr3-IMP2962","unstructured":"European AIDS Clinical Society. EACS guidelines version 7.02 (Updated June 2014. Accessed 28 September 2014.) Available from http:\/\/eacsociety.org\/Portals\/0\/140601_EACS%20EN7.02.pdf."},{"key":"bibr4-IMP2962","unstructured":"Hull M., Cescon A., Raboud J. Switching from first antiretroviral therapy regimen while virologically suppressed is associated with increased risk of subsequent virologic failure.\n                      20th International AIDS Conference\n                      . 20\u201325 July 2014, Melbourne, Australia. Abstract TUAB0103."},{"key":"bibr5-IMP2962","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e32830285fb"},{"key":"bibr6-IMP2962","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e328345ee95"},{"key":"bibr7-IMP2962","unstructured":"US Department of Health and Human Services. Guidance for industry. Antiretroviral drugs using plasma HIV RNA measurements \u2013 clinical considerations for accelerated and traditional approval. (Updated October 2002. Accessed 28 September 2014.) Available from http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm070968.pdf."},{"key":"bibr8-IMP2962","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200201250-00017"},{"key":"bibr9-IMP2962","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-133-1-200007040-00004"},{"key":"bibr10-IMP2962","doi-asserted-by":"publisher","DOI":"10.3851\/IMP1519"},{"key":"bibr11-IMP2962","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.23404"},{"key":"bibr12-IMP2962","first-page":"174","volume":"39","author":"M\u00f6bius U.","year":"2005","journal-title":"J Acquir Immune Defic Syndr"},{"key":"bibr13-IMP2962","doi-asserted-by":"publisher","DOI":"10.1086\/517497"},{"key":"bibr14-IMP2962","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkm413"},{"key":"bibr15-IMP2962","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e31819a226f"},{"key":"bibr16-IMP2962","doi-asserted-by":"publisher","DOI":"10.1086\/528862"},{"key":"bibr17-IMP2962","doi-asserted-by":"publisher","DOI":"10.1086\/378131"},{"key":"bibr18-IMP2962","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1293.2007.00534.x"},{"key":"bibr19-IMP2962","unstructured":"Mills A., Ortiz R., Crofoot G.Jr. 48 Week study of the first PI-based single tablet-regimen (STR) darunavir\/ cobicistat\/emtricitabine\/tenofovir alafenamide versus cobicistat-boosted darunavir and emtricitabine\/tenofovir disoproxil fumarate in treatment-naive adults.\n                      54th Interscience Conference on Antimicrobial Agents and Chemotherapy\n                      . 5\u20139 September 2014, Washington, DC, USA. Abstract H-647c."},{"key":"bibr20-IMP2962","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkq295"}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP2962","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP2962","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:52:22Z","timestamp":1777380742000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.3851\/IMP2962"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,11,1]]},"references-count":20,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2015,11]]}},"alternative-id":["10.3851\/IMP2962"],"URL":"https:\/\/doi.org\/10.3851\/imp2962","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,11,1]]}}}