{"id":2239,"date":"2009-04-16T18:52:43","date_gmt":"2009-04-16T22:52:43","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/current-studies\/results\/"},"modified":"2021-07-01T10:53:02","modified_gmt":"2021-07-01T14:53:02","slug":"results","status":"publish","type":"page","link":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/","title":{"rendered":"Research Results"},"content":{"rendered":"<p>We would like to say <strong>Thank You<\/strong> to all of our past and present study participants!<\/p>\n<div style=\"width: 1140px;\" class=\"wp-video\"><!--[if lt IE 9]><script>document.createElement('video');<\/script><![endif]-->\n<video class=\"wp-video-shortcode\" id=\"video-2239-1\" width=\"1140\" height=\"641\" preload=\"metadata\" controls=\"controls\"><source type=\"video\/mp4\" src=\"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-content\/uploads\/sites\/726\/2020\/04\/VID_20191004_133402.mp4?_=1\" \/><a href=\"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-content\/uploads\/sites\/726\/2020\/04\/VID_20191004_133402.mp4\">https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-content\/uploads\/sites\/726\/2020\/04\/VID_20191004_133402.mp4<\/a><\/video><\/div>\n<p>The generosity of thousands of research participants has made it possible for millions of people to access an array of medications to treat and prevent HIV infections in combinations with medical and psychosocial interventions to improve the health and quality of life for people living with HIV, Hepatitis C, Tuberculosis and other infectious diseases. Below are links that provide research results from most of the studies conducted at our site. If you were a study participant and need assistance finding the research results of the study you participated in, please contact your study coordinator listed <a href=\"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/about\/#ourstaff\">HERE <\/a>or <a href=\"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/contact-us\/\">CONTACT US<\/a> online.<\/p>\n<h3>For prevention study results please visit:<\/h3>\n<p><a href=\"https:\/\/www.hptn.org\/research\/studies\">https:\/\/www.hptn.org\/research\/studies<\/a><\/p>\n<div class=\"btn-group dropdown  oscitas-bootstrap-container\">\n <button type=\"button\" class=\"btn  btn-default oscitas-bootstrap-container dropdown-toggle\" data-toggle=\"dropdown\" aria-haspopup=\"true\" aria-expanded=\"false\">\n<strong>For current participants, please read this letter from our study team regarding the Truvada lawsuit<\/strong> <span class=\"caret oscitas-bootstrap-container\"><\/span> <\/button>\n<ul class=\"dropdown-menu oscitas-bootstrap-container\" role=\"menu\">\n<p><a href=\"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-content\/uploads\/sites\/726\/2019\/09\/Truvada-Lawsuit-Participants.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Please click here for a PDF copy of this letter<\/a><\/p>\n<p><strong>Dear Participants,<\/strong><\/p>\n<p>You may have recently seen or heard about lawsuits filed against <a href=\"https:\/\/www.gilead.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Gilead Sciences<\/a>, the manufacturer of <a href=\"https:\/\/www.truvada.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Truvada<\/a>. This 2-drug tablet was <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2004\/021752s000_Truvada_Approv.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">approved by the FDA in 2004<\/a> to treat HIV, and in 2012, it was <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/appletter\/2012\/021752Orig1s030ltr.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">approved for HIV prevention<\/a> (as <a href=\"https:\/\/www.cdc.gov\/hiv\/risk\/prep\/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">pre-exposure prophylaxis or PrEP<\/a>). Since Truvada is a medication that is being used in our prevention research studies, we want to share information that may answer questions you have about Truvada.<\/p>\n<p><em>Is Truvada safe?<\/em><\/p>\n<p>Truvada is a combination of two drugs: emtricitabine (abbreviated FTC) and tenofovir disoproxil fumarate (abbreviated TDF). We have known for years that TDF can cause some thinning of the bones (a decrease in bone density). For most people, the amount of bone thinning that TDF causes does not meaningfully increase the chance of a broken bone (fracture). There are <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4400413\/\" target=\"_blank\" rel=\"noopener noreferrer\">clear guidelines for when and how to check bone density for people living with and without HIV<\/a>, and healthcare providers take these guidelines into account when they\u2019re deciding whether to check bone density. So far, studies of people taking Truvada for PrEP <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6248833\/\" target=\"_blank\" rel=\"noopener noreferrer\">have not shown any increased risk of broken bones<\/a>. We also know from studies of <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4844450\/table\/T2\/\" target=\"_blank\" rel=\"noopener noreferrer\">people living with HIV taking Truvada<\/a> and <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5597476\/\" target=\"_blank\" rel=\"noopener noreferrer\">people who take Truvada as PrEP<\/a> that if someone stops taking the drug their bone density recovers close to where it was before they started Truvada.<\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3785270\/\" target=\"_blank\" rel=\"noopener noreferrer\">TDF can also cause kidney problems in some people<\/a> \u2013 especially those with diabetes, high blood pressure, or other medical problems that put them at risk for kidney disease. Fortunately, this is uncommon, <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/17545703\" target=\"_blank\" rel=\"noopener noreferrer\">occurring in around 2 of every 100 people who take TDF for treating their HIV<\/a>. It\u2019s also <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/22892171\" target=\"_blank\" rel=\"noopener noreferrer\">reversible for the majority of patients<\/a> living with HIV who have a change in their kidney function related to Truvada. Among participants in studies of Truvada for PrEP, there were just as many people who had kidney function changes taking TDF as those taking the placebo \u2013\u00a0meaning that <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6248833\/\" target=\"_blank\" rel=\"noopener noreferrer\">it didn\u2019t look like Truvada was causing any significant kidney issues<\/a>. It\u2019s important for you to know our research studies include regular blood tests to check on kidney health. Overall, we agree with the FDA that Truvada should be considered safe for the treatment and prevention of HIV. What we know about Truvada and kidney and bone health has not changed since you entered the UNC research study.<\/p>\n<p><em>What are the lawsuits about?<\/em><\/p>\n<p>The lawsuits we are aware of allege that the maker of Truvada (<a href=\"https:\/\/www.gilead.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Gilead Sciences<\/a>) delayed coming out with a new combination drug that appears to have a better safety profile than Truvada. The new drug, called <a href=\"https:\/\/www.descovy.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Descovy<\/a>, contains FTC and an alternative version of TDF called tenofovir alafenamide fumarate (abbreviated TAF). TAF is very similar to TDF but <a href=\"https:\/\/www.poz.com\/article\/TDF-TAF-switch-27580-6994\" target=\"_blank\" rel=\"noopener noreferrer\">has less effect on bone density and a lower likelihood of causing kidney problems<\/a>. The lawsuits do not claim that Truvada has any new or previously undisclosed side effects \u2013 only that the drug company should have come out with the new version (TAF) drug sooner.<\/p>\n<p><em>How have the HIV prevention research studies conducted at UNC changed since the lawsuits were filed?<\/em><\/p>\n<p>Our team works hard to make sure that our participants are monitored closely for any safety issues throughout all of our studies, so these lawsuits have not changed anything that we do for our participants. Blood tests are done routinely, and bone scans are part of many of our prevention studies \u2013 even though they are not part of usual practice for people taking Truvada as PrEP outside of a research study. We are also obligated to inform you if there is any new information that could change the risk of participating in a study (plus it\u2019s just the right thing to do). But the information that your study coordinator reviewed with you during the informed consent process is the same today as it was when you entered the study. There is no new information to share regarding Truvada\u2019s safety.<\/p>\n<p>As of August 2019, Truvada is the only FDA-approved drug for HIV prevention, but newer prevention drugs are being compared to Truvada as the \u201cstandard.\u201d When new options for pre-exposure prophylaxis (PrEP) are approved by the FDA, we are obligated to let you know, so that you can decide whether to continue in the study or to switch to the new medication. We expect some new options to become available over the next several years.<\/p>\n<p>We hope this addresses questions or concerns you may have about Truvada. Please let a study team member know if you have other questions we have not covered.<\/p>\n<p>Thanks,<\/p>\n<p>Study Team<\/ul>\n<\/div>\n<h3>For study results from the AIDS Clinical Trials Group (ACTG) please visit:<\/h3>\n<p><a href=\"https:\/\/actgnetwork.org\/past-study-results\">https:\/\/actgnetwork.org\/past-study-results<\/a><\/p>\n<h3>For results from studies that were sponsored by a pharmaceutical company please visit:<\/h3>\n<p><a href=\"https:\/\/clinicaltrials.gov\/\">https:\/\/clinicaltrials.gov\/<\/a><\/p>\n<h3>For results from the GEMINI study please visit:<\/h3>\n<p><a href=\"https:\/\/www.viiv-studyregister.com\/en\/study\/?id=204861\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.viiv-studyregister.com\/en\/study\/?id=204861<\/a><\/p>\n<p><a href=\"https:\/\/www.trialsummaries.com\/Study\/StudyDetails?id=3676&amp;tenant=MT_VIV_9011\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.trialsummaries.com\/Study\/StudyDetails?id=3676&amp;tenant=MT_VIV_9011<\/a><\/p>\n<h3>For results from the ATLAS-2M study please visit:<\/h3>\n<p><a href=\"https:\/\/www.viiv-studyregister.com\/en\/study\/?id=207966\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.viiv-studyregister.com\/en\/study\/?id=207966<\/a><\/p>\n<p><a href=\"https:\/\/www.trialsummaries.com\/Study\/StudyDetails?id=3724&amp;tenant=MT_VIV_9011\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.trialsummaries.com\/Study\/StudyDetails?id=3724&amp;tenant=MT_VIV_9011<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>We would like to say Thank You to all of our past and present study participants! The generosity of thousands of research participants has made it possible for millions of people to access an array of medications to treat and prevent HIV infections in combinations with medical and psychosocial interventions to improve the health and &hellip; <a href=\"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/\" aria-label=\"Read more about Research Results\">Read more<\/a><\/p>\n","protected":false},"author":11751,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-2239","page","type-page","status-publish","hentry","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Research Results - Global HIV Prevention and Treatment Clinical Trials Unit<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Research Results - Global HIV Prevention and Treatment Clinical Trials Unit\" \/>\n<meta property=\"og:description\" content=\"We would like to say Thank You to all of our past and present study participants! 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The generosity of thousands of research participants has made it possible for millions of people to access an array of medications to treat and prevent HIV infections in combinations with medical and psychosocial interventions to improve the health and &hellip; Read more","og_url":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/","og_site_name":"Global HIV Prevention and Treatment Clinical Trials Unit","article_modified_time":"2021-07-01T14:53:02+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/","url":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/","name":"Research Results - Global HIV Prevention and Treatment Clinical Trials Unit","isPartOf":{"@id":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/#website"},"datePublished":"2009-04-16T22:52:43+00:00","dateModified":"2021-07-01T14:53:02+00:00","breadcrumb":{"@id":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/results\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/"},{"@type":"ListItem","position":2,"name":"Research Results"}]},{"@type":"WebSite","@id":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/#website","url":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/","name":"Global HIV Prevention and Treatment Clinical Trials Unit","description":"Institute for Global Health and Infectious Diseases","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links_to":[],"_links_to_target":[],"_links":{"self":[{"href":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-json\/wp\/v2\/pages\/2239","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-json\/wp\/v2\/users\/11751"}],"replies":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-json\/wp\/v2\/comments?post=2239"}],"version-history":[{"count":0,"href":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-json\/wp\/v2\/pages\/2239\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.med.unc.edu\/medicine\/infdis\/actu\/wp-json\/wp\/v2\/media?parent=2239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}