{"id":22024,"date":"2019-02-13T15:00:59","date_gmt":"2019-02-13T20:00:59","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/?post_type=episode&#038;p=22024"},"modified":"2023-08-04T13:58:58","modified_gmt":"2023-08-04T17:58:58","slug":"participating-in-hiv-cure-research","status":"publish","type":"episode","link":"https:\/\/www.med.unc.edu\/medicine\/news\/chairs-corner\/podcast\/participating-in-hiv-cure-research\/","title":{"rendered":"Participating in HIV Cure Research &#8211; with a UNC Study Participant &amp; Dr. David Margolis"},"content":{"rendered":"<p>What are some reasons to participate in HIV cure research? A UNC research study participant, Rob, shares his personal reasons, and describes his involvement in recent studies. Dr. David Margolis, who leads HIV cure research at UNC, joins the conversation and describes where cure research is today, including specifics on Vorinostat trials, and where their work is headed. Dr. Margolis is a Professor of Medicine, Microbiology and Immunology in the Division of Infectious Diseases and is Director of the HIV Cure Center at UNC. He also is the Principal Investigator for CARE, the Collaboratory of AIDS Researchers for Eradication<\/p>\n<div class=\"image-section\">\n<figure class=\"thumbnail wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium\" src=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/participating-in-hiv-cure-research-image2.jpeg\" alt=\"image2\" width=\"300\" height=\"200\" \/><figcaption class=\"caption wp-caption-text\">David Margolis, MD<\/figcaption><\/figure>\n<\/div>\n<div class=\"alert alert-grey\">\n\u201cBeing part of research to potentially cure the illness has made me feel better about having the illness. I feel like my pain and suffering is going to help someone else eventually.\u201d<br \/>\n\u2013 Rob, HIV research study participant<\/div>\n\n<!-- iframe plugin v.5.2 wordpress.org\/plugins\/iframe\/ -->\n<iframe loading=\"lazy\" width=\"100%\" height=\"166\" scrolling=\"no\" frameborder=\"no\" allow=\"autoplay\" src=\"https:\/\/w.soundcloud.com\/player\/?url=https%3A\/\/api.soundcloud.com\/tracks\/402479613&#038;color=%23646c74&#038;auto_play=false&#038;hide_related=true&#038;show_comments=false&#038;show_user=true&#038;show_reposts=false&#038;show_teaser=true\" class=\"iframe-class\"><\/iframe>\n\n&lt;!&#8211;<span class=\"btn btn-dark btn-large\">\n<!-- iframe plugin v.5.2 wordpress.org\/plugins\/iframe\/ -->\n<iframe loading=\"lazy\" width=\"350\" height=\"20\" scrolling=\"no\" frameborder=\"no\" src=\"https:\/\/w.soundcloud.com\/player\/?url=https%3A\/\/api.soundcloud.com\/tracks\/402479613%3Fsecret_token%3Ds-cTXlf&#038;color=%235fa6dd&#038;inverse=true&#038;auto_play=false&#038;show_user=true\" class=\"iframe-class\"><\/iframe>\n <\/span>&#8211;&gt;<\/p>\n<p>Topics Covered:<\/p>\n<ul>\n<li>Participating in HIV clinical trials<\/li>\n<li>Current trials in HIV at UNC<\/li>\n<li>Aiming for a cure<\/li>\n<li>Research on Vorinostat<\/li>\n<li>Looking to the future<\/li>\n<\/ul>\n<p><b>Ron Falk:<\/b> Hello, and welcome to the Chair\u2019s Corner from the Department of Medicine at the University of North Carolina. This is our series for patients where we talk about HIV. Today is our final and special episode where we welcome a research study participant, Rob, and <a class=\"external-link\" title=\"\" href=\"\/infdis\/about\/faculty\/david-margolis-md\" target=\"_blank\" rel=\"noopener noreferrer\">Dr. David Margolis<\/a>, for a conversation about cure research.<\/p>\n<p>Rob is an active study participant in our clinical trials at UNC, and we are most happy to have him here to share his experience.<\/p>\n<p>Dr. Margolis is a Professor of Medicine, Microbiology and Immunology in our Division of Infectious Diseases and Director of the HIV Cure Center at UNC. He also is the Principal Investigator for CARE, the Collaboratory of AIDS Researchers for Eradication. Welcome, Rob and David.<\/p>\n<p><b>Rob &amp; David Margolis, MD:<\/b> Thank you.<\/p>\n<h3><span class=\"blue\">Participating in HIV clinical trials<\/span><\/h3>\n<p><b>Falk: <\/b>Rob, tell us a little about yourself. Tell us a bit about how long you\u2019ve been participating in research studies.<\/p>\n<p><b>Rob:<\/b> The current study I\u2019m in has been going on for about two years. Before that, I\u2019ve been in too many studies to count, pretty much since I was diagnosed and brought into the ID Clinic. At first, I was in a study combining two different medications, I think Truvada and etravirene, or Intelence\u2014seeing how they work together. That\u2019s how I was initially getting my HIV meds for free, which was great because I didn\u2019t have health insurance at the time. Since then, I\u2019ve pretty much been involved in studies ever since.<\/p>\n<p><b>Falk:<\/b> Go back to the first time you entered a clinical trial. What inspired you to get involved then, at the very outset?<\/p>\n<p><b>Rob:<\/b> The very outset was getting free medication\u2014I didn\u2019t have health insurance. Currently I\u2019m on the ADAP, so that\u2019s taken care of.<\/p>\n<p><b>Falk:<\/b> But you\u2019re still inspired to do it.<\/p>\n<p><b>Rob:<\/b> Of course\u2014it\u2019s changed over time. The money is still a big part of it. It\u2019s more than just the money. I feel like being a part of research, while also being in care here has changed my perspective on having HIV and my treatment in general. When I was first diagnosed and came in, I went through a period of depression, which I think is common for HIV patients, or anyone diagnosed with a chronic illness. Being part of research to potentially cure the illness has made me feel better about having the illness. I feel like my pain and suffering is going to help someone else eventually.<\/p>\n<p><b>Falk:<\/b> There has been a tremendous, incredible change in treatment over your lifetime, so your participation and folks like you has been unbelievably instrumental in the things that Dr. Margolis has been doing. What do you think other people in the community\u2014other folks with HIV\u2014feel about HIV research and treatment? Do you have a sense of that?<\/p>\n<p><b>Rob:<\/b> No, I don\u2019t get out much. I know PrEP is really big right now. I honestly don\u2019t have many friends who have HIV, but I do have other friends who are on PrEP. I feel like just in general, public knowledge about HIV and what treatment is like is really changing from when I was first diagnosed. I encountered a lot of ignorance at first, but PrEP has really changed the conversation. People understand more about how HIV is transmitted, how the drugs work, that\u2019s a big part of it. Prior to being diagnosed, I knew for the most part how HIV was transmitted, but I knew nothing about antiretrovirals and how efficient they are at preventing transmission and what the current research is like.<\/p>\n<p>I feel like public perception is always going to be behind the research, but I feel like things are getting better in terms of what most people know about HIV.<\/p>\n<h3><span class=\"blue\">Current trials in HIV at UNC<\/span><\/h3>\n<p><b>Falk:<\/b> Dr. Margolis, let\u2019s talk a little bit about some of your current trials. Where is cure research today, and then how does the participation of folks like Rob play in what you do?<\/p>\n<p><b>Margolis:<\/b> We have a number of trials that are ongoing. They are a small number and they involve a small amount of people. Really, our approach has been that we\u2019re just at the beginning of HIV cure research. So, these are really more like small experiments than big clinical trials that are going to give an overall answer and get a drug or therapy licensed. Participants like Robert who are willing to stay with us for the long term and study things step by step, are really very important. It\u2019s a very different dynamic than Robert was talking about in the beginning. Earlier when antiretroviral therapy was being devised and perfected, there was a clear benefit for people to be in studies, sometimes to get compensation or access to medication, but the medication itself was their therapy. There was definitely the risk benefit calculation to being in studies that was much easier to understand.<\/p>\n<p>Now, we\u2019re just trying to understand how to make the persistent virus vulnerable to be cleared\u2014what to use to clear the virus to eventually get rid of it. It\u2019s a step-by-step process, one study after another, putting the pieces together. Hopefully, someday people like Robert will benefit from the work we do now, years later, having a therapy that we can actually use in the clinic and eradicate infection. Right now, we need them as our partners to help us make this progress.<\/p>\n<p>Robert has been in some studies where we\u2019ve been looking at the activity of what\u2019s called the latency reversing agent. The drug is called Vorinostat. It affects the human cell, but also forces the virus out of latency to sort of wake up and show itself. We think that\u2019s the first step, to make the latent hidden virus vulnerable. Then we\u2019re using, as a second step, several immunotherapies. The study Robert\u2019s in right now, he\u2019s getting a unique vaccine that\u2019s given over a couple of months to sort of prepare his immune system. We hope to see the virus when it gets woken up so it can be cleared by that immune response. So, I think you\u2019re essentially in the middle of a bunch of cycles of vaccine and Vorinostat, and vaccine and Vorinostat, and later in the spring we\u2019ll try to get assays, very sensitive assays to measure, <i>how much virus can we still detect, and is there less now than there was in the beginning<\/i>?<\/p>\n<h3><span class=\"blue\">Aiming for a cure<\/span><\/h3>\n<p><b>Falk:<\/b> We\u2019ve had several podcasts already in which the message has become pretty clear that if you continue on your medications each and every day, and the virus has disappeared from your blood, you\u2019re going to do really well. What you\u2019re describing is the reality that even if the virus has disappeared from the blood, it hasn\u2019t left the body completely. What you\u2019re hoping to do with this latency reversal drug, is to find the virus or have the virus come out of its hiding spots and then get rid of it once it has re-emerged. The question then, from your perspective, Rob, how important is it for you to really get rid of this virus altogether?<\/p>\n<p><b>Rob:<\/b> It would be great not to be dependent on medication and hopefully we\u2019ll reach that point eventually. I really don\u2019t think about having HIV that much. Before getting diagnosed, I already took medication on a daily basis for something else, so that wasn\u2019t an adjustment for me. It\u2019s really not something that comes up that often. I\u2019ve been managing it just fine.<\/p>\n<p><b>Falk:<\/b> Wouldn\u2019t it be nice though, at some level to really completely get rid of it altogether so you never have to think about it again?<\/p>\n<p><b>Rob:<\/b> Yeah, I guess. I guess my perspective has changed a little bit over time. I have a lot of friends with different chronic illnesses. When I first got HIV, it impacted me a lot, but I realized that this is the best time to have HIV. It\u2019s something I get told by doctors a lot. It\u2019s similar to having high blood pressure. It would be nice not to have to deal with it, and not to worry about where am I going to get my medication from if our health care system collapses\u2014<i>Am I going to die?\u2014<\/i>that\u2019s stressful. As of now, things are okay. We were told upfront, \u201c<i>Don\u2019t expect to be cured by these studies<\/i>.\u201d I\u2019m not in it for that. I\u2019m in it to help people in the future.<\/p>\n<p><b>Margolis:<\/b> That\u2019s very important, but it should also be said that a lot of people with HIV like Robert are sort of dealing with it, and there\u2019s some uncertainty and concern over time about their future health and access to medicines, but many people also feel very stigmatized and very burdened by this chronic \u201cSword of Damocles\u201d hanging over their head\u2014<i>what will happen tomorrow, next week, next month, next year?<\/i> Then on the global, social scale, I don\u2019t know that if we could treat people for a few months and then have virus eradication, achieve a cure, wouldn\u2019t that be better than having to provide chronic medical care for a chronic illness to millions of people around the world?<\/p>\n<p><b>Falk:<\/b> I must admit I take blood pressure medicines and if somebody could figure out a way for me to stop taking blood pressure medicine, and have that go away I would be thrilled to stop taking a daily drug.<\/p>\n<h3><span class=\"blue\">Research on Vorinostat<\/span><\/h3>\n<p><b>Falk:<\/b> The drug that you\u2019re taking now, say it out loud again.<\/p>\n<p><b>Rob:<\/b> For my treatment, or for the study?<\/p>\n<p><b>Falk:<\/b> For the study.<\/p>\n<p><b>Rob:<\/b> Vorinostat.<\/p>\n<p><b>Falk:<\/b> Do you have any symptoms from taking Vorinostat?<b> <\/b><\/p>\n<p><b>Rob:<\/b> Not that I\u2019ve noticed.<\/p>\n<p><b>Falk:<\/b> Pretty easy to take. Can you tell us, Dr. Margolis, a little bit more about this drug and what you\u2019re learning from folks like Rob who are taking it?<\/p>\n<p><b>Margolis:<\/b> Vorinostat is in a class of drugs, there are several of them. They were originally developed for cancer treatment, for oncology, and their target against mechanisms in the normal cell. They were developed in cancer therapy, because when you target those cells in cancer cells, they tend to die, whereas in normal cells there is less of an effect. There is still some effect in normal cells. When a normal cell has a virus in it, targeting those mechanisms also reverses latency in HIV virus and if it\u2019s in the sleeping, \u201coff\u201d state, takes it towards the \u201con\u201d state and makes the virus be expressed, the cell makes viral proteins, and can be seen by the immune system.<\/p>\n<p><b>Falk:<\/b> So, kick it out of the cell. How effective has this been in your experience so far?<\/p>\n<p><b>Margolis:<\/b> It\u2019s very effective in the lab, and we can measure effects of it reliably in people, but there\u2019s really a second step that I think has to come after the virus proteins are expressed in the cell. The immune system has to see that cell, and it\u2019s a very rare cell spread all over the body, hidden in various places. I think the immune system has to be augmented to be better than usual at finding HIV and killing HIV infected cells. So far, just giving Vorinostat has disturbed latency, but has not depleted any persistently infected cells in people. So, now in all of our studies, we are trying to put something on top of Vorinostat, an antibody, a vaccine, an immune cellular therapy or something else.<\/p>\n<p><b>Rob:<\/b> Before doing the current study with Vorinostat, I did a similar study with creating the vaccine that Dr. Margolis was just talking about. Now the current study I\u2019m in is combining both of those therapies. Prior to this study there was a separate study just testing the Vorinostat.<\/p>\n<p>At first, I declined to be in that study because I was concerned about possible side effects of Vorinostat. I did further research, and once the next opportunity came up, I decided that it was worth the risk. We were using really low dosages compared to what would be used for cancer treatment. I feel like there have been enough studies so far that I feel fine with taking it. I\u2019ve had friends who are not happy with me taking Vorinostat, since there\u2019s been limited testing on healthy people, but someone has to take the risk. I\u2019m single, I don\u2019t have kids, I work from home, I have a lot of free time, so I\u2019m in a unique position to help. So far, no problems.<\/p>\n<p><b>Falk:<\/b> That\u2019s great news.<\/p>\n<p><b>Margolis:<\/b> This really illustrates exactly the challenges, but at the same time what\u2019s so great. Robert took the vaccine and we know exactly how it works in him because we measured it. Then he took Vorinostat, and we know exactly how it works in him because we measured it. Now we can put them together and find out exactly how well they work together.<\/p>\n<p><b>Falk:<\/b> Do you take regular sorts of HIV drugs at the same time, or just those two?<\/p>\n<p><b>Rob:<\/b> I\u2019m taking Triumeq daily. It\u2019s a combination of antiretrovirals as part of my treatment, separate from the study.<\/p>\n<p><b>Falk:<\/b> That\u2019s just for usual maintenance care. If this drug doesn\u2019t work, are there other latency reversal drugs on the horizon?<\/p>\n<p><b>Margolis:<\/b> We have several immunotherapies, clearance therapies that we\u2019re testing. Actually, out in the field in other research groups, there are quite a number of these sorts of approaches. On the latency reversal side, what we have discovered so far is somewhat more limited. There are only a few, one or two or three things, that can be tested in people now. Our research program is trying to develop new agents, and we have some new agents that we just discovered that are moving into animal testing. We hope maybe in a couple of years to be able to move them into the clinic as well.<\/p>\n<p><b>Falk:<\/b> It\u2019s a huge advantage to have the same person, like you, Rob, who is willing to participate in one study after the other, because otherwise, one doesn\u2019t know the effects of combination therapy if you don\u2019t know the effects of each drug by itself. Your willingness to participate in one of these after the other is unbelievably useful for the community as a whole, there\u2019s no doubt about that. Why have you stayed involved?<\/p>\n<p><b>Rob:<\/b> I have made personal bonds with the people. I don\u2019t get to see Dr. Margolis that much, actually, but some of the research assistants, it\u2019s nice seeing the same people every now and then and have forged some friendships.<\/p>\n<p>I\u2019ve also just learned a lot about HIV and just how research is done in general and how the FDA works. I\u2019ve used that in my personal life. I took a peer outreach class at ECU, and I\u2019ve done a couple workshops on HIV prevention. I\u2019ve really gotten a lot out of it\u2014I have nothing but good things to say.<\/p>\n<p><b>Falk:<\/b> Good. If somebody is listening to this podcast and is thinking about joining a clinical trial, what would you tell them?<\/p>\n<p><b>Rob:<\/b> Yes, definitely do it\u2014or look into it. There are so many different studies going on in addition to HIV research. We live in one of the best places to be in the world for medical research, so there\u2019s plenty of opportunities to get involved. You don\u2019t have to take experimental drugs. I used to be terrified of needles, believe it or not, and this has been really good exposure therapy for me. I can\u2019t look when I get stabbed still, but I\u2019ve come a long way. There are a lot of opportunities to get involved\u2014look into it. it\u2019s worth it.<\/p>\n<h3><span class=\"blue\">Looking to the future<\/span><\/h3>\n<p><b>Falk:<\/b> Dr. Margolis, just looking to the future, this whole concept of latency reversal and then getting rid of the virus once it rears its ugly head again, what are the next steps? Where is that all headed?<\/p>\n<p><b>Margolis:<\/b> I think things are sort of headed towards a convergence of many different areas of HIV research that perhaps can be used together. Robert talked about taking a combination pill which is three or sometimes four different medicines in one pill, it lasts all day, and that\u2019s the entire therapy you need to take. There now are developments trying to deliver those medications in other ways where they would last for three to six months or perhaps even a year.<\/p>\n<p><b>Falk:<\/b> So, you no longer would need to take daily therapy.<\/p>\n<p><b>Margolis:<\/b> You would need to get an implant or an injection once every several months. That could serve for treatment, that could serve as a preventive treatment if someone was at risk of being exposed. At the end of when we get to whatever treatments we\u2019re going to do to flush the virus out and allow the immune system to clear infection, we probably will always worry, just like with cancer, that there\u2019s some cell left behind\u2014we missed one or two places. We probably want to have an insurance policy in place for some period of time, like a vaccine or a long-lasting therapy. When we believe that we\u2019ve cleared infection, someone could still become infected again\u2014they\u2019re now at risk of new infection, potentially. If we had a vaccine or preventive therapy, that would provide an insurance policy against relapse of infection, or re-infection.<\/p>\n<p><b>Falk:<\/b> Really exciting, no question about it. Rob and David Margolis, thank you so much for participating in this podcast.<\/p>\n<p><b>Rob\/Margolis: <\/b>It\u2019s been a pleasure. Thank you.<\/p>\n<p><b>Falk:<\/b> Thanks so much to our listeners for tuning in. If you have enjoyed this series, please take a moment and <a href=\"https:\/\/itunes.apple.com\/us\/podcast\/unc-department-of-medicine-chairs-corner\/id1076686662?mt=2\" target=\"_blank\" rel=\"noopener noreferrer\">subscribe to the Chair\u2019s Corner on iTunes<\/a> and leave us a rating and comment. You can also find us on <a class=\"external-link\" title=\"\" href=\"https:\/\/soundcloud.com\/chairscorner\" target=\"_blank\" rel=\"noopener noreferrer\">SoundCloud<\/a> and the UNC Department of Medicine web site and on <a href=\"https:\/\/www.facebook.com\/UNCDeptMedicine\" target=\"_blank\" rel=\"noopener noreferrer\">FaceBook<\/a>.<\/p>\n<div class=\"alert alert-blue width:100% \">\n<p><strong>Visit these sites for more information:<\/strong><\/p>\n<ul>\n<li><a class=\"external-link\" title=\"\" href=\"\/infdis\/about\/faculty\/david-margolis-md\" target=\"_blank\" rel=\"noopener noreferrer\">Dr. David Margolis&#8217;s School of Medicine profile<\/a><\/li>\n<li><a class=\"external-link\" title=\"\" href=\"\/infdis\/clinical-care\/infectious-diseases-clinic\" target=\"_blank\" rel=\"noopener noreferrer\">Infectious Diseases (ID) Clinic at UNC<\/a><\/li>\n<li><a class=\"external-link\" title=\"\" href=\"http:\/\/www.med.unc.edu\/ncaidstraining\/\" target=\"_blank\" rel=\"noopener noreferrer\">North Carolina AIDS Training and Education Center<\/a><\/li>\n<li><b><a id=\"LPlnk776044\" href=\"http:\/\/www.thebody.com\/\">TheBody.com<\/a><\/b><\/li>\n<li><a class=\"external-link\" title=\"\" href=\"http:\/\/globalhealth.unc.edu\" target=\"_blank\" rel=\"noopener noreferrer\">UNC Institute for Global Health and Infectious Disease<\/a><\/li>\n<li><a class=\"external-link\" title=\"\" href=\"http:\/\/globalhealth.unc.edu\/news\/feature-stories\/vorinostat-dosing\/\" target=\"_blank\" rel=\"noopener noreferrer\">&#8220;Vorinostat Dosing Exposes Latent HIV&#8221; &#8211; article describing recent results<\/a><\/li>\n<\/ul>\n<\/div>\n<p>\/\/ <\/p>\n","protected":false},"excerpt":{"rendered":"<p>What are some reasons to participate in HIV cure research? A UNC research study participant, Rob, shares his personal reasons, and describes his involvement in recent studies. Dr. David Margolis, who leads HIV cure research at UNC, joins the conversation and describes where cure research is today, including specifics on Vorinostat trials, and where their &hellip; <a href=\"https:\/\/www.med.unc.edu\/medicine\/news\/chairs-corner\/podcast\/participating-in-hiv-cure-research\/\" aria-label=\"Read more about Participating in HIV Cure Research &#8211; with a UNC Study Participant &amp; Dr. David Margolis\">Read more<\/a><\/p>\n","protected":false},"featured_media":4525,"menu_order":0,"template":"","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","_links_to":"","_links_to_target":""},"podcast-category":[636,664,639],"class_list":["post-22024","episode","type-episode","status-publish","has-post-thumbnail","hentry","podcast-category-podcast-hiv-matters","podcast-category-podcast-patient-stories","podcast-category-podcast","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Participating in HIV Cure Research - with a UNC Study Participant &amp; Dr. David Margolis | Department of Medicine<\/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\/news\/chairs-corner\/podcast\/participating-in-hiv-cure-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Participating in HIV Cure Research - with a UNC Study Participant &amp; Dr. David Margolis | Department of Medicine\" \/>\n<meta property=\"og:description\" content=\"What are some reasons to participate in HIV cure research? A UNC research study participant, Rob, shares his personal reasons, and describes his involvement in recent studies. 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