{"id":235,"date":"2011-05-23T15:49:00","date_gmt":"2011-05-23T15:49:00","guid":{"rendered":"https:\/\/new.igihe.com\/final-trial-of-microbicide-ring-to-be-conducted\/"},"modified":"2011-05-23T15:48:02","modified_gmt":"2011-05-23T15:48:02","slug":"final-trial-of-microbicide-ring-to-be-conducted","status":"publish","type":"post","link":"https:\/\/new.igihe.com\/english\/final-trial-of-microbicide-ring-to-be-conducted\/","title":{"rendered":"Final trial of microbicide ring to be conducted in Rwanda"},"content":{"rendered":"<p><p>Rwanda is in the third and final phase of testing a vaginal ring containing <span data-scaytid=\"1\" data-scayt_word=\"antiretrovirals\">antiretrovirals<\/span>, which, if successful, could provide an important female-controlled method of HIV prevention.&nbsp;<\/p>\n<p> Malawi, Rwanda, South Africa and Zimbabwe have all been selected to conduct the final phase of the trial. Phases I and II &#8211; conducted in Kenya, Malawi, Rwanda, South Africa &#8211; assessed the safety and acceptability of a daily application of a gel containing the <span data-scaytid=\"2\" data-scayt_word=\"ARV\">ARV<\/span>,<a href='http:\/\/www.ipmglobal.org\/our-work\/ipm-product-pipeline\/dapivirine-tmc120' target=\"_blank\"><span data-scaytid=\"4\" data-scayt_word=\"dapivirine\">dapivirine<\/span><\/a>.&nbsp;<\/p>\n<p> &#8220;Phases I and II were completed successfully&nbsp;; this means that the <span data-scaytid=\"7\" data-scayt_word=\"microbicide\">microbicide<\/span> has been evaluated and found to be safe and acceptable,&#8221; Gilles <span data-scaytid=\"11\" data-scayt_word=\"Ndayisaba\">Ndayisaba<\/span>, the principal investigator at Project <span data-scaytid=\"59\" data-scayt_word=\"Ubuzima\">Ubuzima<\/span>. &#8220;Even if in Rwanda we conducted phase I and II on the gel, these phases have been done with the ring in several others [countries] and they were successful,&#8221; he added.&nbsp;<\/p>\n<p> Phase I trials involved small numbers of women, followed by expanded safety trials, Phase I\/II, which gathered additional safety data among more participants over longer periods. Once the safety trials are complete, longer-term safety and efficacy trials begin. Phase III trials are conducted among high-risk participants so that researchers can see if there is a difference in infection rates between women who use the active <span data-scaytid=\"8\" data-scayt_word=\"microbicide\">microbicide<\/span> product versus those who use a placebo. This phase looks specifically at the efficacy and gathers information to proceed with putting the product on the general market.&nbsp;<\/p>\n<p> In Rwanda, the trials are being conducted by a local NGO, Project <span data-scaytid=\"14\" data-scayt_word=\"Ubuzima\">Ubuzima<\/span>, with the&nbsp;<a href='http:\/\/www.ipmglobal.org\/' target=\"_blank\">International Partnership for <span data-scaytid=\"20\" data-scayt_word=\"Microbicides\">Microbicides<\/span><\/a>. The project has carried out safety trials for <span data-scaytid=\"5\" data-scayt_word=\"dapivirine\">dapivirine<\/span> gel among more than 60 women and has conducted an HIV incidence study among 1,250 female <span data-scaytid=\"21\" data-scayt_word=\"VCT\">VCT<\/span> clients and 800 high-risk women in the capital, Kigali, in preparation for the final phase.&nbsp;<\/p>\n<p> An estimated 3,000 HIV-negative women aged between 18 and 40 will participate in the trial in all selected countries &#8211; between 400 and 600 will come from Rwanda&nbsp;; the trial is expected to last three years.&nbsp;<\/p>\n<p> &#8220;Potential participants are well-educated on clinical research in general and first have to sign an informed consent form which includes all information concerning risks and benefits while participating in the study,&#8221; said Marie-Michelle <span data-scaytid=\"22\" data-scayt_word=\"Umulisa\">Umulisa<\/span>, the community outreach manager at Project <span data-scaytid=\"15\" data-scayt_word=\"Ubuzima\">Ubuzima<\/span>. &#8220;These are reviewed by the Rwandan National Ethics Committee to protect participants\u2019 rights.&#8221;&nbsp;<\/p>\n<p> Each participant will use the ring for a minimum 15 months or a maximum 33 months. &#8220;It is likely that products that can be applied less frequently like the ring will be more acceptable and will achieve better adherence,&#8221; <span data-scaytid=\"12\" data-scayt_word=\"Ndayisaba\">Ndayisaba<\/span> said. &#8220;Vaginal rings need only to be replaced every four weeks and may therefore have benefits over dosage forms that need to be used more frequently.&#8221;&nbsp;<\/p>\n<p> The researchers say <span data-scaytid=\"6\" data-scayt_word=\"dapivirine\">dapivirine<\/span> is advantageous because it is not used in current HIV\/AIDS treatment regimens so there is less potential for drug resistance. They say the vaginal ring is cheap to manufacture, comfortable, flexible and can be self-inserted&nbsp;; it is intended to provide long-term protection during anticipated and unanticipated sexual intercourse.&nbsp;Uncertainties&nbsp;<\/p>\n<p> According to Evelyn <span data-scaytid=\"24\" data-scayt_word=\"Kestelyn\">Kestelyn<\/span>, executive director of Project <span data-scaytid=\"16\" data-scayt_word=\"Ubuzima\">Ubuzima<\/span>, there are advantages to being one of the countries conducting a trial. &#8220;When the products finally come on the market&#8230; countries that were selected to implement phase III will get the products for free or will purchase them at a subsidized price.&#8221;&nbsp;<\/p>\n<p> However, women in Kigali remain uncertain about whether they would use a <span data-scaytid=\"9\" data-scayt_word=\"microbicide\">microbicide<\/span> ring should the ongoing trial prove successful.&nbsp;<\/p>\n<p> &#8220;I would need to be extremely sure it works well before I can entrust my life with such a thing&nbsp;; I mean I would want to be sure it doesn\u2019t have any particular side-effects,&#8221; said Agatha <span data-scaytid=\"25\" data-scayt_word=\"Ingabire\">Ingabire<\/span>.&nbsp;<\/p>\n<p> Should the product make it on to the market, Project <span data-scaytid=\"17\" data-scayt_word=\"Ubuzima\">Ubuzima<\/span> plans a major campaign to sensitize Rwandans on the <span data-scaytid=\"26\" data-scayt_word=\"microbicide\u2019s\">microbicide\u2019s<\/span> function.&nbsp;<\/p>\n<p> &#8220;We intend to undertake a huge sensitization process, starting with community leaders and gradually we shall trickle this down to the other masses,&#8221; said <span data-scaytid=\"23\" data-scayt_word=\"Umulisa\">Umulisa<\/span>. &#8220;Community acceptability of this project is key for its success.&#8221;&nbsp;<\/p>\n<p> Globally, a number of&nbsp;<a href='http:\/\/www.ipmglobal.org\/sites\/international.ixm.ca\/files\/ClinicalTrialsFactSheet_APR11.pdf' target=\"_blank\"><span data-scaytid=\"10\" data-scayt_word=\"microbicide\">microbicide<\/span> trials<\/a>&nbsp;are ongoing, testing gels and rings. In 2010, the biggest&nbsp;[success->http:\/\/www.plusnews.org\/Report.aspx?ReportId=89895]&nbsp;was recorded in a study by the Centre for the AIDS <span data-scaytid=\"27\" data-scayt_word=\"Programme\">Programme<\/span> of Research in South Africa, which found that a vaginal gel containing the <span data-scaytid=\"3\" data-scayt_word=\"ARV\">ARV<\/span> <span data-scaytid=\"28\" data-scayt_word=\"tenofovir\">tenofovir<\/span> was 39 percent effective in reducing a woman\u2019s HIV risk when used for about three-quarters of sex acts and 54 percent effective when used more consistently.&nbsp;<\/p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Rwanda is in the third and final phase of testing a vaginal ring containing antiretrovirals, which, if successful, could provide an important female-controlled method of HIV prevention.&nbsp; Malawi, Rwanda, South Africa and Zimbabwe have all been selected to conduct the final phase of the trial. Phases I and II &#8211; conducted in Kenya, Malawi, Rwanda, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[75],"byline":[277],"hashtag":[],"class_list":["post-235","post","type-post","status-publish","format-standard","hentry","category-health","tag-homenews","byline-igihe-com-reporter"],"bylines":[{"id":277,"name":"IGIHE.com Reporter","slug":"igihe-com-reporter","description":"","image":{"id":0,"url":"https:\/\/secure.gravatar.com\/avatar\/?s=96&d=mm&f=y&r=g","alt":"Default avatar","title":"Default avatar","caption":"","mime_type":"image\/jpeg","sizes":[]},"user_id":null}],"contributors":[{"id":277,"name":"IGIHE.com Reporter","slug":"igihe-com-reporter","description":"","image":{"id":0,"url":"https:\/\/secure.gravatar.com\/avatar\/?s=96&d=mm&f=y&r=g","alt":"Default avatar","title":"Default avatar","caption":"","mime_type":"image\/jpeg","sizes":[]},"user_id":null}],"featured_image":null,"_links":{"self":[{"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/posts\/235","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/comments?post=235"}],"version-history":[{"count":0,"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/posts\/235\/revisions"}],"wp:attachment":[{"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/media?parent=235"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/categories?post=235"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/tags?post=235"},{"taxonomy":"byline","embeddable":true,"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/byline?post=235"},{"taxonomy":"hashtag","embeddable":true,"href":"https:\/\/new.igihe.com\/english\/wp-json\/wp\/v2\/hashtag?post=235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}