{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:12:59Z","timestamp":1777378379525,"version":"3.51.4"},"reference-count":16,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2012,11,1]],"date-time":"2012-11-01T00:00:00Z","timestamp":1351728000000},"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":["AIDS Research and Human Retroviruses"],"published-print":{"date-parts":[[2012,11]]},"abstract":"\n Sexual transmission accounts for the majority of new HIV infections worldwide with sexually exposed cervicovaginal and colorectal mucosae being primary sites of infection. Two recent Phase 1 rectal microbicide trials included, as an ancillary endpoint, suppression of\n ex vivo<\/jats:italic>\n HIV infection of\n in vivo<\/jats:italic>\n microbicide-exposed rectal mucosal tissue biopsies. Both trials demonstrated significant suppression of biopsy infectibility in drug-exposed versus placebo-exposed tissue. This potential early\n biomarker of efficacy<\/jats:italic>\n has raised the feasibility of utilizing \u201csnap-frozen\u201d tissue samples, acquired at multiple trial sites to be shipped for central processing, providing a mechanism to correlate tissue drug concentrations with a functional index of HIV prevention. While previous reports have indicated acceptable comparability of fresh versus freeze-thawed cervicovaginal tissue samples, no similar evaluations with colorectal tissue biopsies have been done. In this study, rectal biopsies from healthy, HIV-seronegative participants were assessed for structural integrity (histology), viability (MTT assays), and tissue infectibility to compare results from fresh versus combinations of freeze\/thaw protocols. Results indicated that while all protocols showed equivalent viability with fresh samples (MTT), histology documented poor preservation of tissue integrity following freezing. Infectibility results from freeze-thawed colorectal tissue were markedly lower (usually<25% of fresh samples) and varied greatly and unpredictably. Centralized colorectal tissue infectibility assays using biopsies from remote trial sites cannot currently be supported under these protocols.\n <\/jats:p>","DOI":"10.1089\/aid.2012.0062","type":"journal-article","created":{"date-parts":[[2012,7,25]],"date-time":"2012-07-25T23:17:17Z","timestamp":1343258237000},"page":"1509-1512","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":16,"title":["Nonreproducibility of \u201cSnap-Frozen\u201d Rectal Biopsies for Later Use in\n Ex Vivo<\/i>\n Explant Infectibility Studies"],"prefix":"10.1177","volume":"28","author":[{"given":"Ian","family":"McGowan","sequence":"first","affiliation":[{"name":"University of Pittsburgh School of Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Tanner","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie","family":"Elliott","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"Ibarrondo","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elena","family":"Khanukhova","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charina","family":"McDonald","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terry","family":"Saunders","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Zhou","sequence":"additional","affiliation":[{"name":"UCLA School of Public Health"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter A.","family":"Anton","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2012,11,1]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0023243"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e32834b3629"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.aids.0000232230.96134.80"},{"key":"e_1_3_3_5_2","volume-title":"18th Conference on Retroviruses and Opportunistic Infections","author":"Anton P","unstructured":"Anton P, , Cranston R, , Carballo-Dieguez A, , Kashuba A, , Khanukhova E, , Elliot J et al. RMP-02\/MTN-006: A Phase 1, placebo controlled trial of rectally applied 1% vaginal tenofovir gel with comparison to oral tenofovir disoproxil fumarate. 18th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2011Abstract 34LB."},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200008180-00011"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1089\/aid.2006.22.419"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01328-07"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4615-4143-1_1"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0167-5699(97)81663-5"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cryobiol.2007.08.008"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/del508"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e318156ef16"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2008.05.084"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00673-09"},{"key":"e_1_3_3_16_2","first-page":"493","article-title":"A simple method of estimating fifty per cent end-points","volume":"27","author":"Reed LJ","year":"1938","unstructured":"Reed LJ, , Muench H. A simple method of estimating fifty per cent end-points. 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