{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T09:40:14Z","timestamp":1791020414327,"version":"4.1.0"},"reference-count":22,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2013,4,1]],"date-time":"2013-04-01T00:00:00Z","timestamp":1364774400000},"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":[[2013,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Tenofovir gel, used vaginally before and after coitus, reduced women's acquisition of HIV by 39%. This is a safety assessment of tenofovir gel, including renal, bone, gastrointestinal, genital and haematological parameters.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In the Centre for the AIDS Programme of Research in South Africa (CAPRISA) 004, a double-blind, randomized placebo-controlled trial, 445 of the 889 eligibly enrolled women were assigned to tenofovir gel. All participants were advised to use the gel vaginally only, with one dose of gel within 12 h before and a second dose as soon as possible after sex, with no more than two doses in 24 h. Clinical and laboratory safety data were collected at monthly and quarterly visits, respectively. Genital assessments were undertaken at enrolment and quarterly thereafter, or as indicated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Women assigned to tenofovir gel were exposed to an average monthly vaginal dose of 240 mg of tenofovir (six applications). In total, six women, three in each group, had mild creatinine elevations, all of which occurred in July\/ August 2008. The incidence of anaemia was 3.5 and 3.8 per 100 women-years in tenofovir and placebo groups, respectively ( P=0.80). Of the six women (four tenofovir and two placebo) experiencing bone fractures, none were associated with abnormal phosphate or calcium values. The proportion of women with diarrhoea was higher in the tenofovir gel group (17% versus 11%; P=0.026). There was no significant increase of any genital adverse event in the tenofovir group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>No significant renal, haematological, genital or bone effects were associated with the use of tenofovir gel. Aside from a puzzling increase in diarrhoea, tenofovir gel has an excellent safety profile.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3851\/imp2311","type":"journal-article","created":{"date-parts":[[2012,8,23]],"date-time":"2012-08-23T06:37:53Z","timestamp":1345703873000},"page":"301-310","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":20,"title":["Safety of Tenofovir Gel, a Vaginal Microbicide, in South African Women: Results of the Caprisa 004 Trial"],"prefix":"10.1177","volume":"18","author":[{"given":"David C","family":"Sokal","sequence":"first","affiliation":[{"name":"FHI 360, Clinical Sciences Department, Durham, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quarraisha Abdool","family":"Karim","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"},{"name":"Department of Epidemiology, Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sengeziwe","family":"Sibeko","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nonhlanhla","family":"Yende-Zuma","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leila E","family":"Mansoor","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"Baxter","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anneke","family":"Grobler","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"Frolich","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayesha BM","family":"Kharsany","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nomsa","family":"Miya","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koleka","family":"Mlisana","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Maarshalk","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salim S Abdool","family":"Karim","sequence":"additional","affiliation":[{"name":"CAPRISA \u2013 Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa"},{"name":"Department of Epidemiology, Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2013,4,1]]},"reference":[{"key":"bibr1-IMP2311","unstructured":"UNAIDS. UNAIDS Report on the global AIDS Epidemic 2010. Geneva: Joint United Nations Programme on HIV\/ AIDS. (Updated 11 February 2011. Accessed 11 February 2011.) Available from http:\/\/www.unaids.org\/globalreport\/."},{"key":"bibr2-IMP2311","doi-asserted-by":"publisher","DOI":"10.1126\/science.1193748"},{"key":"bibr3-IMP2311","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e3182253c19"},{"key":"bibr4-IMP2311","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60878-7"},{"key":"bibr5-IMP2311","volume-title":"Package insert","author":"Viread (tenofovir disoproxil fumarate).","year":"2008"},{"key":"bibr6-IMP2311","doi-asserted-by":"publisher","DOI":"10.1097\/QAD.0b013e3280b07b33"},{"key":"bibr7-IMP2311","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2010.318"},{"key":"bibr8-IMP2311","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1293.2005.00318.x"},{"key":"bibr9-IMP2311","doi-asserted-by":"publisher","DOI":"10.1089\/apc.2007.0052"},{"key":"bibr10-IMP2311","doi-asserted-by":"publisher","DOI":"10.1086\/644785"},{"key":"bibr11-IMP2311","unstructured":"Mulligan K., Glidden D., Gonzales P. Effects of FTC\/ TDF on bone mineral density in seronegative men from 4 continents: DEXA results of the Global iPrEx Study.\n                      18th Conference of Retroviruses and Opportunistic Infections\n                      . 27 February\u20132 March 2011, Boston, MA, USA. Abstract 94LB."},{"key":"bibr12-IMP2311","volume-title":"Investigators brochure: tenofovir gel (GS-1278)","author":"Gilead Sciences Inc","year":"2010"},{"key":"bibr13-IMP2311","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2011.01.005"},{"key":"bibr14-IMP2311","unstructured":"MedDRA\n                      \u00ae\n                      . Medical Dictionary for Regulatory Activities. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (Updated 1 March 2013. Accessed 27 March 2013.) Available from http:\/\/www.meddramsso.com\/."},{"key":"bibr15-IMP2311","unstructured":"Division of AIDS. Table for grading adult and pediatric adverse events. NIAID DAIDS Regulatory Support Center (RSC). (Updated 14 March 2013. Accessed 27 March 2013.) Available from http:\/\/rsc.tech-res.com\/safetyandpharmacovigilance\/gradingtables.aspx."},{"key":"bibr16-IMP2311","doi-asserted-by":"publisher","DOI":"10.1159\/000180580"},{"key":"bibr17-IMP2311","unstructured":"MacQueen K., van Loggerenberg F., Weaver M. Behavioral recall accuracy in a microbicide trial: effects of psychological stress, serostatus, and timing of interview.\n                      M2010 Microbicides Conference: Building Bridges in HIV Prevention\n                      . 22\u201325 May 2010, Pittsburgh, PA, USA. Abstract 408."},{"key":"bibr18-IMP2311","unstructured":"Nuttall J., Kashuba A., Wang R. The pharmacokinetics of tenofovir following intravaginal and intrarectal administration of tenofovir gel to rhesus macaques in a microbicide trial.\n                      M2010 Microbicides Conference.\n                      22\u201325 May 2010, Pittsburgh, PA, USA. Abstract 40."},{"key":"bibr19-IMP2311","doi-asserted-by":"publisher","DOI":"10.1097\/01.aids.0000210608.70762.c3"},{"key":"bibr20-IMP2311","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1011205"},{"key":"bibr21-IMP2311","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1108524"},{"key":"bibr22-IMP2311","unstructured":"Marrazzo J., Ramjee G., Nair G. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir\/emtricitabine, or vaginal tenofovir gel in the VOICE Study (MTN 003).\n                      Conference on Retroviruses and Opportunistic Infections\n                      . 3\u20136 March 2013, Atlanta, GA, USA. Abstract 26LB."}],"container-title":["Antiviral Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP2311","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.3851\/IMP2311","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T12:51:16Z","timestamp":1777380676000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.3851\/IMP2311"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,4]]},"references-count":22,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2013,4]]}},"alternative-id":["10.3851\/IMP2311"],"URL":"https:\/\/doi.org\/10.3851\/imp2311","relation":{},"ISSN":["1359-6535","2040-2058"],"issn-type":[{"value":"1359-6535","type":"print"},{"value":"2040-2058","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,4]]}}}