{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:18:16Z","timestamp":1777378696387,"version":"3.51.4"},"reference-count":14,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2010,11,1]],"date-time":"2010-11-01T00:00:00Z","timestamp":1288569600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["AIDS Research and Human Retroviruses"],"published-print":{"date-parts":[[2010,11]]},"abstract":"<jats:p>\n                    Treatment options for HIV-infected patients can be limited due to viral drug resistance to antiretroviral agents. Enfuvirtide (ENF) is an injectable entry\/fusion inhibitor that is effective in achieving viral suppression when used in combination with protease inhibitors (PIs) in patients with pre-existing resistance. However, ENF treatment is associated with injection site reactions and dosing fatigue. This multicenter, open-label, Phase IIIb, 48-week pilot study assessed safety, tolerability, and effectiveness of the PI darunavir (DRV), boosted with ritonavir (DRV\/r), and the non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine (ETR), when substituted for ENF\/PI (\u00b1NNRTI)-based therapy. Ten virologically suppressed (HIV RNA less than 50\u2009copies\/ml) men who were intolerant to ENF were enrolled. Median (range) CD4+ count was 301 (187\u2013663) cells\/mm\n                    <jats:sup>3<\/jats:sup>\n                    . Two patients discontinued the study; all remaining patients maintained a viral load of less than 50\u2009copies\/ml at Week 48. Viral load increased to greater than 50\u2009copies\/ml in two patients, but was eventually re-suppressed without the need for changes in treatment. Median (range) increase (last observation carried forward) in CD4+ count from baseline to Week 48 was 64 (\u201353\u2013100) cells\/mm\n                    <jats:sup>3<\/jats:sup>\n                    . Two grade 3 adverse events (AEs), nausea and weight loss, and one serious AE, acute cholecystitis, were reported; each AE resolved without treatment interruption. Most common AEs related to study drug were fatigue, rash, headache, and diarrhea. Decreases in triglycerides, low-density lipoprotein, and high-density lipoprotein, were observed. This study suggests that a DRV\/r- and ETR-based regimen can be substituted for an ENF-based regimen while maintaining virologic suppression.\n                  <\/jats:p>","DOI":"10.1089\/aid.2009.0285","type":"journal-article","created":{"date-parts":[[2010,11,17]],"date-time":"2010-11-17T17:44:50Z","timestamp":1290015890000},"page":"1215-1219","source":"Crossref","is-referenced-by-count":3,"title":["A 48-Week Pilot Study Switching Suppressed Patients to Darunavir\/Ritonavir and Etravirine from Enfuvirtide, Protease Inhibitor(s), and Non-nucleoside Reverse Transcriptase Inhibitor(s)"],"prefix":"10.1177","volume":"26","author":[{"given":"Peter","family":"Ruane","sequence":"first","affiliation":[{"name":"Light Source Medical"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Alas","sequence":"additional","affiliation":[{"name":"Light Source Medical"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Ryan","sequence":"additional","affiliation":[{"name":"Tibotec, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Perniciaro","sequence":"additional","affiliation":[{"name":"Tibotec Therapeutics"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Witek","sequence":"additional","affiliation":[{"name":"Tibotec Therapeutics"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2010,11,1]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1D143"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.qai.0000185314.56556.c3"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1089\/apc.2006.0174"},{"key":"e_1_3_3_5_2","unstructured":"FUZEON\u00ae (enfuvirtide): Full prescribing information. http:\/\/www.rocheusa.com\/products\/fuzeon\/pi.pdf. 2009July27th."},{"key":"e_1_3_3_6_2","unstructured":"PREZISTA\u00ae (darunavir) Tablets: Full prescribing information. http:\/\/www.prezista.com\/prezista\/documents\/us_package_insert.pdf. 2009 July 15."},{"key":"e_1_3_3_7_2","unstructured":"INTELENCE\u00ae (etravirine) Tablets: Full prescribing information. http:\/\/www.intelence-info.com\/intelence\/assets\/pdf\/INTELENCE_PI.pdf. 2009 September 17."},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e3283316a5e"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)60497-8"},{"key":"e_1_3_3_10_2","first-page":"125","article-title":"Update of the drug resistance mutations in HIV-1: Fall 2006","volume":"14","author":"Johnson VA","year":"2006","unstructured":"Johnson VA, , Brun\u2013Vezinet F, , Clotet B et al. Update of the drug resistance mutations in HIV-1: Fall 2006. Top HIV Med, 2006; 14:125\u2013130.","journal-title":"Top HIV Med"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e32832b4377"},{"key":"e_1_3_3_12_2","volume-title":"Presented at: 15th Conference on Retroviruses and Opportunistic Infections","author":"Haubrich R","year":"2008","unstructured":"Haubrich R, , Cahn P, , Grinsztejn B et al. DUET-1: Week 48 results of a Phase III randomized double-blind trial to evaluate the efficacy and safety of etravirine (ETR; TMC125) versus placebo in 612 treatment-experienced HIV-1-infected patients. Presented at: 15th Conference on Retroviruses and Opportunistic Infections, 2008 Boston http:\/\/www.retroconference.org\/2008\/PDFs\/790.pdf. 2009 June 9."},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61048-4"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61047-2"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2009.09.025"}],"container-title":["AIDS Research and Human Retroviruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/aid.2009.0285","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/aid.2009.0285","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/aid.2009.0285","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T09:12:00Z","timestamp":1777367520000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/aid.2009.0285"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2010,11]]},"references-count":14,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2010,11]]}},"alternative-id":["10.1089\/aid.2009.0285"],"URL":"https:\/\/doi.org\/10.1089\/aid.2009.0285","relation":{},"ISSN":["0889-2229","1931-8405"],"issn-type":[{"value":"0889-2229","type":"print"},{"value":"1931-8405","type":"electronic"}],"subject":[],"published":{"date-parts":[[2010,11]]}}}