• CAB member highlight: Angel Hernandez, University of Puerto Rico

    June 30, 2019 pendari Uncategorized

    University of Puerto Rico CAB member Angel Hernández is committed to ensuring that clinical research is translated to his largely rural community in ways that are not only understandable, but also culturally appropriate. A CAB member since 2010, Hernandez is concerned about an aging population in which 72% of PLWH are 45 years or older, research is often misunderstood, and services can be irregular.

    “While the PLWH in our community receive adequate health services,” he notes, “we still lack enough clinics with extended service hours; consistent availability of ART for inpatients at hospitals; availability of integrated primary care; and provision of support services. Our community also faces ageism, stigmas, and discrimination.”

    Hernandez responds with an impressive commitment to bridging those gaps. Since joining the ACTG, he has served on the AEC, SASC, CSC, and ITSG, as the CSS co-chair, and as part of the Forum for Collaborative HIV Research, as well as on several protocol development teams. He is also proud to have been part of the team that developed the Feedback to CAB Protocol Draft Feedback procedure, and has also collaborated on the development of the CSS scientific agenda priorities.

    What he has seen has instilled a number of priorities in Angel, which he and his colleagues are working to move forward. “My hopes for the ACTG and HIV research are to continue studies on new formulations with less toxicities that are easier to take,” he says. “A high priority should be the focus on aging issues, and increased efforts to include underrepresented populations in clinical trials. Of upmost importance is to conduct research on the long-term effects of HIV and ART in long-term survivors.”

    As for his personal legacy, Angel adds: “I want to be remembered as an active advocate who brought the concerns of participants in clinical trials to the table.”

  • Investigator highlight: Dr. Aadia Rana, University of Alabama-Birmingham, School of Medicine

    June 30, 2019 pendari Uncategorized

    ACTG researcher Dr. Aadia Rana is Associate Professor of Medicine at the University of Alabama-Birmingham and an Investigator with the Alabama CRS. Aadia’s ACTG career began in 2010 when she started working as a site investigator at The Miriam Hospital CRS under Dr. Karen Tashima. Concurrent with her NIH-funded research, which addressed the need to improve care for and treatment adherence among people living with HIV, Aadia focused on developing strategies to promote recruitment, retention, and adherence in populations poorly represented in research studies as a member of the ACTG Underrepresented Populations Committee (2012-2016). In 2015, she also joined the Long-Acting Therapy Working Group of the ARTS and the Hard-to-Reach Populations Working Group.

    Through these groups, Dr. Rana and Dr. Jose Castillo-Mancilla submitted a proposal in 2016 to compare the use of long-acting injectable antiretroviral therapy versus standard of care in individuals with a history of non-adherence to care and treatment. This proposal developed into A5359, Long-Acting Therapy to Improve Treatment SUccess in Daily LifE, A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals (LATITUDE), which started enrolling participants in May 2019. LATITUDE tests a combination novel therapeutic strategy of injectable ART supported by short-term conditional economic incentives to improve outcomes in a challenging population. In 2017, Aadia Rana moved to UAB, where she co-directs the Ending HIV in Alabama Scientific Working group at the UAB Center for AIDS Research and became an Investigator with the ARTS.

  • Publications: Can Text Messaging Support Adherence for People Failing Secong-Line Therapy in Low- and Middle-Income Countries (MULTI-OCTAVE Study [A5288])

    June 30, 2019 pendari Uncategorized

    (ACTG) A5288 (MULTI-OCTAVE) is one of the first studies to look at interventions for medication adherence in lower-income and middle-income countries (LMICs) for individuals failing second line therapy. All participants in this unprecedented prospective interventional study were failing 2nd line ART, with the majority on lopinavir/ritonavir-based ART. Participants were either kept on that regimen or randomized to receiving third line ART regimens based on the results of viral genotyping on enrollment, and followed for a median of 72 weeks.

    A randomized cell phone-based adherence support intervention was conducted among most of the study participants. In the intervention, field staff would text participants to see how they were doing in terms of taking the ART and participants would text back, first daily and then tapering down to once a week. The study showed a small (but not significant) benefit of a mobile phone-based intervention for ART adherence on the primary outcome of achieving virological suppression at 48 weeks, and a small (and statistically significant) effect on the outcome of time to virological failure.

    The authors conclude that adherence behavior is challenging and that two-way text messaging might help a bit, but does not seem to be as fruitful as hoped.  Therefore, more research on this and other adherence support strategies are needed.

    Gross R, Ritz J, Hughes MD, Salata R, Mugyenyi P, Hogg E, Wieclaw L, Godrey C, Wallis CL, Mellors JW, Mudhune VO, Badal-Faesen S, Grinsztejn B, Collier AC. Two-way mobile phone intervention compared with standard-of-care adherence support after second-line antiretroviral therapy failure: a multinational, randomized controlled trial. Lancet Digital Health 2019; 1: e26–34

  • Publications: OPTIONS Study (A5241) Asks Whether NRTIs are Essential in Salvage Regimens

    June 30, 2019 pendari Uncategorized

    When people with HIV develop resistance to antiretroviral medications, their clinicians often prescribe previously-used nucleoside reverse transcriptase inhibitors (NRTIs), along with other drugs, in the new “salvage” regimen, reasoning that the NRTIs may improve the chances of treatment response. These extra drugs may result in side effects, however, and it is not certain if they’re necessary if other active medicines are included in the salvage regimen. In the OPTIONS trial (ACTG A5241), the AIDS Clinical Trials Group asked whether NRTIs are an essential component of salvage regimens if the regimen has other active medications.

    The OPTIONS trial included more than 350 people with HIV who had received many different treatment regimens and developed resistance to a variety of medications before entering. The trial, which lasted almost 2 years, showed that clinicians do not need to add NRTIs to salvage regimens, as long as the new regimen has a cumulative activity of 2 or more active medicines from other drug classes.  Salvage regimens that did not include NRTIs gave similar rates of durable virologic suppression as those that included NRTIs. This means that clinicians and people with HIV can be confident that they don’t need to add NRTIs as long as the rest of the regimen is strong enough. Fortunately, with newer and better antiretroviral medications, most people with HIV will have treatment options that result in successful control of the virus. By avoiding NRTIs when we don’t need them, we reduce the pill burden, side effects and the expense of extra medicines.

    There were other important findings from the trial. The study found that younger people and those starting fewer new medications were less likely to achieve HIV suppression with salvage therapy. This means that we need to make extra efforts to make sure younger people and those who receive fewer new medicines are able to achieve successful control of their HIV. The study also used a questionnaire to assess participants’ quality of life scores before and during the study: participants in the trial had significant improvement in their scores, demonstrating the strong link between effective treatment and quality of life.

    The participation of hundreds of people with HIV who took part in the OPTIONS trial, many of whom had received treatment for more than a decade before they joined, has already made a difference: treatment guidelines have changed thanks to the contribution of the study participants and the staff at the many ACTG sites in the OPTIONS trial.

    Gandhi RT, Tashima KT, Smeaton LM, Vu V, Ritz J, Andrade A, Eron JJ, Hogg E, Fichtenbaum C. Long-term Outcomes in a Large Randomized Trial of HIV-1 Salvage Therapy: 96-week Results of AIDS Clinical Trials Group A5241 (OPTIONS). Journal of Infectious Diseases 2019 May 28
    (Accompanying editorial: Hoenig M, Little S. Salvage Antiretroviral Therapy: Time for “DeNUKElearization”?)

  • LATITUDE Study (A5359) Garners Widespread Media Attention

    June 30, 2019 pendari Uncategorized

    The LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life trial (ACTG A5359) study received extensive media attention on its recent opening. LATITUDE is evaluating long-acting ART (monthly injections of injections of rilpivirine and cabotegravir) in individuals who have difficulty adhering to daily oral ART. The study, which opened in May at several U.S. sites, garnered significant media attention in outlets including POZ, Bloomberg, Pharmafile, and many others. Read the study news release here. Congratulations to the LATITUDE team on the successful launch of this important new trial!

  • PHOENIx MDR-TB Study Prepares to Open

    June 30, 2019 pendari Uncategorized

    PHOENIx (Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (A5300B/I2003B/) is a Phase III, open-label, multicenter trial to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active TB among high-risk household contacts (HHCs) of adults (index case) with multidrug-resistant tuberculosis (MDR-TB). This ACTG/IMPAACT cross-network collaboration expects to follow 5610 participants (~2158 index cases and 3452 HHCs) for 96 weeks.

    Twenty-seven potential participating sites from 12 countries (Botswana, Brazil, Haiti, India, Kenya, Peru, Philippines, South Africa, Tanzania, Thailand, Uganda, Zimbabwe) are eligible to apply to participate in PHOENIx. Each participating site will have a run-in phase, where the site will demonstrate its capacity to identify adults with MDR-TB (index cases), access their HHs, screen HHCs, and enroll and follow eligible HHCs. While the study opening has been delayed for a number of requested protocol changes, we now anticipate two sites (Botswana: Gabarone/12701 and Brazil: Chagas/12101) opening for enrollment this month, with others to follow.

    Congratulations to the PHOENIx’s team persistence and resilience as the study prepares to get underway! PHOENIx is critical to define the best way to prevent TB in contacts of those with MDR-TB and will have profound implications for preventative TB care worldwide.

  • Mentoring Comes Full Circle: ACTG Mentee Becomes the Mentor

    June 18, 2015 pendari Uncategorized

    Meet Timothy Wilkin, MD

    Timothy Wilkin, MD, MPH, is an Associate Professor of Medicine in the Division of Infectious Diseases at the Weill Cornell Medical College and also serves as the Cornell-Chelsea Clinical Research Site Leader and Chair of the ACTG Co-Infections and Malignancy Working Group. Dr. Wilkin has been with the ACTG Network since 2003 and credits his decision to focus on HIV/AIDS research to Michael Para, MD, Professor of Infectious Disease at The Ohio State University who inspired him during his medical school training.

    “Dr. Para had a tremendous impact on my decision to focus my career on HIV/AIDS. During my first year of medical school he invited one of his patients with HIV, who was also an activist, to speak to my class,” said Wilkin. “She opened my eyes to the rampant stigma that HIV-infected individuals encountered and she impressed me with all that she did to enlighten her community while living with advanced AIDS. That was the starting point for me.”

    During his clinical years in medical school, Dr. Wilkin was a witness to the dramatic change in the way people living with HIV were cared for as HIV protease inhibitors and combination therapy entered clinical practice.  He feels fortunate to have worked with Dr. Para and his patients to see firsthand how those therapies helped to change their lives.  At the same time, Tim also had a major impact on some of his mentors as well.

    “While in medical school, Tim was one of those great students who have an idea, the motivation to carry it out and the work ethic to see it to completion. When the fourth year student curriculum was changing in Tim’s senior year, he asked to develop a month long elective on the long term care of the HIV-infected patient who spoke to his class.  He organized the course, set-up the daily activities, the readings and the evaluation,” said Dr. Para. “I actually still use much of the course material he generated for that month long course. I think that shows just how passionate he was with regard to HIV/AIDS care and research, even during medical school.”

    Dr. Wilkin has participated in nine ACTG protocol teams (including eight as Protocol Chair or Vice-Chair) during his tenure with the ACTG Network.  He led the development of AMC052/ACTG A5246, a clinical trial that established the safety and immunogenicity of the quadrivalent HPV vaccine in HIV-infected men.  Currently, he is the Study Chair of two ongoing clinical trials: A5298 and A5282.  A5298 is a phase III trial of the quadrivalent HPV vaccine in HIV-infected men and women.  This study is the first randomized efficacy study of the HPV vaccine in HIV-infected adults and will be the first to examine the efficacy of the vaccine in a highly HPV-exposed population.   

    Dr. Wilkin developed A5282 alongside his collaborator, Cindy Firnhaber, MD, Associate Professor, Department of Internal Medicine, Director Clinical HIV Research Unit University of Witwatersrand.  Together, they were able to secure support from a NIAID/PEPFAR collaboration to help cover expensive infrastructure costs.  Cervical cancer prevention is a new area of research for many of the participating A5282 sites.  

    “Dr. Firnhaber has had an amazing impact on the care of women with HIV in South Africa,” said Wilkin. “She has led efforts to implement cervical cancer screening services for tens of thousands of HIV-infected women.  She has a wonderful team with whom I am fortunate to collaborate.”  

    Dr. Wilkin was also last year’s recipient of the Wofsy Award given to investigators who are active in the care of HIV-positive women and for researching questions important to women living with HIV.

    “It was a complete shock; I had no idea that I won the award until they announced my name,” said Wilkin.  “It is a tremendous honor and I am very proud to be included with the list of previous awardees.”

    Tim also believes that being on an ACTG protocol team or ACTG scientific committee places him in the company of highly experienced clinical researchers and world-class scientists who are shaping the way care is provided for people living with HIV.  The established investigators he has worked with over the years have taught him a great deal about how to conduct successful, high-quality clinical trials.

    To make his journey from medical student to ACTG Principle Investigator come full circle, Dr. Wilkin has recently begun mentoring younger investigators and he hopes to share all of his years of experience with them. 

    “I enjoy working with younger investigators to develop their careers in clinical research,” said Wilkin. “In addition to the joy of seeing their success, these relationships are invigorating my research efforts and are leading to exciting new collaborations.”

  • Nurse Takes Time to Listen

    March 31, 2015 pendari Uncategorized

    The dry erase board in Cheryl Keenan’s office at Brigham and Women’s Hospital in Boston is filled with lists of letters and numbers. Each combination represents an HIV research study being conducted by either industry or the AIDS Clinical Trials Group (ACTG) Network. Keenan is the site’s sole research nurse. She manages roughly 20 HIV and hepatitis C virus (HCV) clinical trials, and the dry erase board helps her keep everything straight.

    “Without research there cannot be a cure,” Keenan says.

    After working for 15 years in the intensive care unit (ICU), she made the switch four years ago to infectious diseases research. Keenan sees people living with HIV who have enrolled in one of the ACTG’s studies being conducted at the Brigham and Women’s site. She check patients’ vital signs, draws blood and ensures they are not experiencing any negative side effects from the study’s medications.  

    Paul Sax, MD, is the Clinical Research Site Leader of the ACTG’s Brigham and Women’s location.

    “Cheryl came to us with extensive experience in cardiovascular disease research, which has been invaluable for several of our ACTG studies,” says Sax. “She already had a great understanding of cardiovascular issues, and then quickly learned the HIV- and hepatitis C virus-specific treatments as well. One of the consistent things I have heard from our study subjects ever since she joined our team is how compassionate and caring she is, even in the context of research. Many of them consider her like a primary care provider, as she’s is their first and major contact with our clinic!”

    Keenan says the population of study participants she sees in Boston is diverse. Although she sees more men than women, she knows there are women living with HIV in the area and she makes an extra effort to reach out to them.

    “I have a wonderful relationship with all of my patients,” Keenan says. “I know them well and they know me well. I think they know that they can reach out to me day or night for anything. Listening, really listening to people and doing what you can based on their needs is what I love to do.”

    Keenan discusses with her study participants what other clinical trials they would like to see the ACTG develop. Cure research is the response she hears most often.

    “Cure studies do require more personal time and commitment from our patients to get these more intensive studies completed,” Keenan says. “I have a few very committed individuals willing to take on more time consuming studies because they know we cannot have results without their time and commitment. They are very important to HIV research. I have many of my patients enrolled in the ACTG’s A5322 study investigating HIV and aging. They are all eager to contribute to science in one way or another. Many of my patients are involved in research because they just want to give back. They may not have much free time, but they still participate.”

    When she is not seeing patients at the ACTG’s Brigham and Women’s site, Keenan can be found spending time with her two children and husband. She also relaxes with a walk along the shore.

    “If I have free time, you can usually find me on the beach with my yellow labs,” she says. “But don’t worry, I can still answer my email.”

  • Nurse Finds Knack for Data

    January 1, 1970 pendari Uncategorized

    Sharon Kohrs, RN, has watched her career progress from an inpatient nurse to a research nurse to a data and quality assurance manager. One constant over the years has been the patient population she serves – people living with HIV.

    “I am never bored with my work,” says Kohrs. “I have met the most amazing people over the years and have seen the disease progress to a manageable condition rather than one of fear. I have been able to experience the early years, when I worked on an inpatient HIV/AIDS unit, to now seeing people living everyday lives – having families, working and managing their disease. All these years later, I still see an amazing group of dedicated people working hard every day to fight HIV. They awe and inspire me.”

    Kohrs has worked as a research nurse and data manager at the AIDS Clinical Trials Group (ACTG) Network’s Cincinnati Clinical Research Site (CRS) for the past 22 years. From 1992 to 1996, she served as the site’s research nurse seeing clinical trial participants during study visits. Then in 1996, she was asked to review the site’s case report forms. Clinical studies use a series of case report forms to consistently collect data on everything from a patient’s vital signs to medical history.

    “I seem to have a knack for it and initially quality assurance became about 25 percent of my work,” Kohrs says. “That quickly increased to about 50 percent of my work with an agreement that I would continue to follow the people I had on study, but not take on any new participants so that eventually I would be doing 100 percent quality assurance.”

    Kohrs’ last group of study participants rolled off of study last year. These were people who volunteered for the ACTG’s ALLRT study. The trial began in 2000 as follow-up study for people living with HIV in the United States who were already enrolled in a parent ACTG study. The goal of the trial was to follow people living with HIV for an average of five years or longer after starting anti-HIV treatment to better understand the long-term effects of the virus and anti-HIV medications. Thanks to the rich database collected over the study’s 13 years, investigators have made breakthroughs in immune recovery, inflammatory markers, opportunistic infections and cure research.

    Tammy Miller, RN, is the Cincinnati CRS Coordinator. She attended nursing school with Kohrs. They immediately connected because they were “non-traditional” students in a very otherwise “traditional” class of bachelor of science in nursing degree students, most of them younger and unencumbered with family-rearing responsibilities. The two of them quickly realized they had both faced loss and grief in their lives, both at a very young age, so it took no time for a lifelong friendship to ensue. Kindred spirits, facing parenting, college and life issues together they soon realized another very important connection – they each had a deep passion for persons living with AIDS. From that point forward, their separate career paths move ahead, sometimes in parallel and sometimes intertwine, but always in the same direction – caring for persons with HIV/AIDS infection.

    “What best sums up our relationship, both personal and professional, is a quote from the artist Brian Andreas ‘You’re the strangest person I met she said and I said you too and we decided we’d know each other a very long time,’” says Miller. “Always professional and deeply committed to the highest standards of quality, Sharon’s famous motto which will live in infamy is ‘If it’s not written down, it DIDN’T happen!!!’”    

    Now fully engrossed in the data management role at the Cincinnati site, Kohrs begins each day checking data reports. She then pulls the schedules of upcoming study participants’ visits for each nurse. The rest of her day varies between chart reviews, keying data, participating in meetings and responding to any computer issues.

    Carl Fichtenbaum, MD, is the Cincinnati CRS Leader. He calls Kohrs a roll-up-your- sleeves-jump-right-in-how-can-I-help-out type of person.

    “Sharon is a very careful critical thinker. She is able to really tease out protocols and understand what we are supposed to do. She has developed a system of quality assurance that has helped us succeed over the past two decades within the ACTG.  Our nurses go to her often to ensure that they are doing things the right way.  Whenever I have a question about interpreting a protocol, I always recommend we go to Sharon for help.  She has developed relationships nationally within the ACTG and is very well respected,” Fichtenbaum says. “Sharon is an incredibly giving person. She always knows when people are struggling in their personal lives. She is very involved in her church. Sharon and her husband, David, work with younger couples and provide support to those in need.” 

    With her roots in nursing, Kohrs often thinks of the people she used to treat on study. She would like to see future ACTG studies address the issues facing an aging population of people living with HIV.

    “I’m always curious about our long-time HIV infected population,” she says.

    When she is not ensuring the integrity of the data being collected at the Cincinnati site, Kohrs can be found hiking and camping with her family. Her favorite place to visit is Glacier National Park in Montana.

  • National Latino AIDS Awareness Day

    January 1, 1970 pendari Uncategorized

    By Dr. Jose Castillo-Mancilla

    Hispanic/Latinos are the fastest growing minority ethnic group in the United States, accounting for 17 percent of the current population. This is projected to increase to 31 percent by 2060. As we celebrate the National Latino AIDS Awareness Day, it is time to think about how HIV/AIDS affects the Hispanic/Latino community in the US and what can you do to stop it.

    The CDC indicates that more than 95,000 U.S. Hispanic/Latinos have died of HIV/AIDS since the beginning of the epidemic, and that this disease continues to affect us disproportionately. About 20 percent of the new HIV infections occur in individuals of Hispanic/Latino ethnicity, both men and women, and the lifetime likelihood of being diagnosed with HIV/AIDS in is higher for Hispanic/Latinos compared to whites. This also translates into a much more advanced disease stage once the diagnosis is made, which is fueled by factors such as lack of healthcare access, health illiteracy, poverty, stigma and misinformation. Altogether, these elements make our community more vulnerable to HIV/AIDS, which is unacceptable.

    The good news is that Hispanic/Latinos are strong and determined. We have demonstrated that we can move forward and defeat adverse circumstances, but we can only do this if we stand united and fight as one. This year’s National Latino AIDS Awareness Day goal is “Commit to Act.” The following are powerful actions you can take to gain control of your health and control of HIV.

    Take action #1

    If you do not know your HIV status, get tested today. Not knowing whether you have HIV is the main risk factor to develop AIDS and the main reason why you can infect others. Even if you do not think you are at risk, you should get tested at least once. This is no different than getting tested for diabetes or high cholesterol. If your healthcare provider does not offer you a test, ask for one. Knowing your status will help stop the spread of HIV/AIDS.

    Take action #2

    If you are infected with HIV, get into care. Once you have been diagnosed, it is time to act and see a healthcare provider. You may feel fine and think you can wait, but starting treatment early is the best you can do to remain healthy and protect others. The longer treatment is delayed, the longer it will take to control the virus and recover your immune system. Every day you delay care is a day you are at risk.

    Take action #3

    If you are in care, stay in care. There is little benefit on seeing you provider once and not following up. Multiple estimates indicate that only 40 percent of HIV-infected individuals in the US remain in care. This is a real problem because it puts you at risk for advanced disease and of infecting others. If you have difficulty keeping appointments or face barriers, ask for help. Many community-based organizations can help you “navigate the system” so that you can get healthy and stay healthy.

    Take action #4

    If you have been prescribed HIV medications, take your pills. The antiretrovirals are your bridge to health. By taking your medications, you can control the virus and become undetectable. This way, you can stop the progression from HIV to AIDS and you can reduce transmission to others along with other safe sex practices such as condoms. If you have side effects from your medications, ask your healthcare provider and together you can find a treatment option that will be best for you.

    Take action #5

    If you want to help, participate in research studies. Studies have shown very little participation from Hispanic/Latinos in HIV research, which limits our understanding of the disease in our ethnic group. Clinical trials are excellent ways to find out which treatments are the best and to develop new treatment strategies to control the virus, and new research is aiming at curing HIV. If you do not know about HIV research, ask your healthcare provider or visit the AIDS Clinical Trials Group (ACTG) Network’s website http://actgnetwork.org/trials_open_enrollment. Since 1987, the ACTG has conducted studies to find more effective and better tolerated anti-HIV medications. The Network also researches common co-infections people living with HIV also face including hepatitis C virus and tuberculosis. Participating in research is the best way for you to help future generations and fight back against HIV/AIDS.