Press Releases and Announcements
Want to become a member of one of the many ACTG committees? ACTG Committee Nominations are now open for Leadership positions. The application and eligibility requirements can be found here. The deadline for nominations is August 18. The application for general membership will be available on August 23

The application for small clinical trials advancing HIV remission and cure are now open. More information can be found here. The deadline for applications is September 1.

At the end of July, the ACTG announced the launch of A5391, the Do IT study. The study evaluates the effects of an ARV change among people living with HIV who experience excessive weight gain. Read more HERE.
Possible Immune-related Events in A5370 Participants with HIV who Received an Anti-PD-1 Inhibitor

Immune checkpoint inhibitors are a kind of immunotherapy that have been successful at mediating immune responses and reversing T cell exhaustion (a progressive loss of effector function due to prolonged antigen stimulation), and represent a tremendous advance in cancer therapy. Because T-cell exhaustion may be a barrier to HIV cure and because CD4+ T cells expressing PD-1 are enriched for latent HIV, treatment with anti-PD-1 antibodies may be an effective strategy for targeting the latent HIV reservoir in cure research.

A5370 was conducted to determine the safety of the anti-PD-1 antibody (an immune checkpoint inhibitor) cemiplimab, and whether it could reverse T cell exhaustion in people living with HIV, based on prior research indicating that cemiplimab could improve HIV-specific responses and reverse HIV latency. A5370 was a phase 1/2a double-blind, placebo-controlled, dose-escalating safety and immunotherapeutic study of two infusions of cemiplimab in virally suppressed people living with HIV. Four of the five participants enrolled were randomized to receive 0.3 mg/kg of cemiplimab at weeks 0 and 6 (the lowest intended dose for A5370) and one participant received placebo.

The study was stopped early at the lowest dose to be studied after two of the four participants developed possible or probable immune-related events of thyroiditis and hepatitis, which had earlier occurred in individuals receiving similar antibodies for cancer treatment. Details about the cases are below:
  • Case 1. A 50-year-old man had abnormal thyroid function labs four weeks after the first cemiplimab infusion (after normal baseline labs), consistent with hyperthyroidism. The hyperthyroidism was later confirmed on evaluation by an endocrinologist and assessed as probably related to cemiplimab. Thyroid function labs normalized by week 24 without medical intervention. Mild fatigue, his only symptom, resolved.
  • Case 2. A 57-year-old male had normal liver function tests at screening. The liver function labs were mildly elevated (grade 1) just prior to the first infusion of cemiplimab, and markedly elevated (grade 3) two weeks following the first infusion. Hepatology consultation determined that the events were possibly related to cemiplimab, though there was also significant alcohol exposure the evening prior to the visit and chronic alcohol abuse. A liver biopsy was not performed. His liver function labs resolved 35 days after the infusion without intervention.
Per the study protocol, the second infusion was held for both participants, and the other two participants experienced no treatment-related adverse events. Due to the probability of one immune-related event, and the possibility of a second, the safety monitoring committee recommended halting study enrollment and holding further cemiplimab infusions. Given the lack of anticipated direct benefit to study participants and the frequency of possible/probable immune-related events at the lowest intended dose of the study drug, the study was closed. Notably, studies of other similar antibodies have shown an acceptable safety profile in people living with HIV who were treated for cancer. Whether well-suppressed HIV infection in otherwise healthy individuals without cancer contributed to an increased risk of these events in this study remains unknown.

Gay CL, Bosch RJ, McKahnn A, Moseley KF, Wimbish CL, Hendrickx SM, Messer M, Furlong M, Campbell DM, Jennings C, Benson C, Overton ET, Macatangay BJC, Kuritzkes DR, Miller E, Tressler R, Eron JJ, Hardy WD; A5370 Team. Suspected Immune-Related Adverse Events With an Anti-PD-1 Inhibitor in Otherwise Healthy People With HIV. J Acquir Immune Defic Syndr. 2021 Aug 15;87(5):e234-e236. doi: 10.1097/QAI.0000000000002716. PMID: 33929394; PMCID: PMC8263135.

Increasing Understanding of Heart Failure among People Living with HIV

We know from previous studies that people living with HIV face a higher risk of heart failure, a condition in which the heart is unable to pump enough oxygen-carrying blood to meet the body’s needs. Heart failure can be caused by a build-up of fat in the heart muscle cells, which is also known as myocardial steatosis. An ancillary study of REPRIEVE/A5332 (the world’s largest study of heart-related disease prevention in people living with HIV) looked at possible risk factors for myocardial steatosis among people living with HIV who were taking antiretroviral therapy (ART). All of the 82 participants underwent cardiac magnetic resonance spectroscopy, a non-invasive imaging test that measures fat in the heart muscle cells. Among the participants, 88 percent were born male, 41 percent were Black, and 28 percent were Hispanic.
REPRIEVE researchers found that intramyocardial triglyceride (IMTG) content (the higher the IMTG content, the more fat build-up in the heart muscle cells) was higher than average among 52 percent of participants. Factors that tended to be associated with increased build-up of fat in the heart muscle cells included older age, history of intravenous drug use, lower nadir CD4 counts (a person’s lowest known total CD4 count), and being overweight/obese.
These data contribute to our knowledge of factors that might predispose people living with HIV to myocardial steatosis. Studies like this one will help researchers develop strategies to prevent fat build-up in the heart muscle cells with the ultimate goal of finding ways to lower the risk of heart failure among people living with HIV.

Neilan TG, Nguyen KL, Zaha VG, Chew KW, Morrison L, Ntusi NAB, Toribio M, Awadalla M, Drobni ZD, Nelson MD, Burdo TH, Van Schalkwyk M, Sax PE, Skiest DJ, Tashima K, Landovitz RJ, Daar E, Wurcel AG, Robbins GK, Bolan RK, Fitch KV, Currier JS, Bloomfield GS, Desvigne-Nickens P, Douglas PS, Hoffmann U, Grinspoon SK, Ribaudo H, Dawson R, Goetz MB, Jain MK, Warner A, Szczepaniak LS, Zanni MV. Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S63-S69. doi: 10.1093/infdis/jiaa245. PMID: 32645158; PMCID: PMC7347082.

Investigator Spotlight
Jane Simoni, PhD, University of Washington

Jane M. Simoni, Ph.D., a licensed clinical psychologist, is Professor and Director of Clinical Training in the Department of Psychology at the University of Washington (UW) in Seattle. She is the Associate Director of the UW/Fred Hutch CFAR and Director of the new UW Behavioral Research Center for HIV (BIRCH).
Born and raised in a small town in Massachusetts, Jane “always knew” she wanted to be a psychologist, an academic dream she pursed as an undergrad at Princeton and graduate student at UCLA. It was not, however, until her postdoctoral training at USC and Columbia that she began to work in the HIV arena, where she was drawn to study how behavioral factors such as HIV disclosure, stigma, mental health, and cultural values impacted medication adherence and HIV health outcomes. She focuses on intervention research, developing and evaluating culturally and theoretically grounded strategies to promote health, especially among marginalized populations. She has led NIH-funded intervention studies in New York City, Seattle, the U.S.-Mexico border, Beijing, Shanghai, Haiti, and U.S./Kenya. Her current work examines the acceptability of long-acting antiretroviral treatment and digital technology to enhance intervention impact and dissemination. Formerly funded by a K24 mentor award, she is passionate about training doctoral students and early career scientists, having served on the mentoring teams on 37 pre- and post-doctoral training awards and for several R25 and T32 centers.
Within the ACTG, she chairs the Behavioral Science Subcommittee (BSS) with Co-Chair Ivan Balan, Ph.D. She is excited about the opportunities to contribute to ACTG trials through behavioral science, which she views as a continuation of the work she has done for the past nine years as co-chair of HANC’s Behavioral Science Consultative Group for all the NIAID networks.
A resident of the Pacific Northwest for the last 21 years, Jane enjoys being outdoors and active, including gardening, hiking, biking, kayaking, stand-up paddling, and playing tennis and soccer with her wife now that their 18 year-old daughter has headed off to college.
Site Spotlight
Vanderbilt Therapeutics CRS, Nashville, Tennessee, USA

Vanderbilt Therapeutics (VT) has been an ACTG site for just over two decades. Over such a long period of time, personnel transitions are inevitable. Very recently, two of their core long-term staff members (with a combined 35 years of experience at the site!) retired. In response, the site added two outstanding new members to their ACTG team – Anna Tate, BSN, RN and Kira Zemanick, BSN, RN, MHA. . Anna will recruit, enroll and follow participants on ACTG studies. Before joining the VT CRS team, Anna worked at the Comprehensive Care Clinic (CCC) – Vanderbilt’s large HIV primary care clinic. Kira, who is the new regulatory coordinator for the site, previously worked in the CCC’s Pathways Clinic, providing intensive support to patients who face extreme challenges with medication adherence Anna and Kira join the outstanding team of research nurses at VT CRS, including Beverly Woodward, MSN, RN (Research Coordinator), Joan Gottesman, BSN, RN (co-Chair of the ACTG Field Representatives Working Group and a field representative on A5401/ACTIV-2 and A5383), Morgan Lima, MSN, RN (who coordinated cohort studies for their Tennessee CFAR before becoming more engaged with ACTG when COVID-19 paused the HIV cohort studies, and is a Field Rep on A5403 - the GET IT RIGHT Study), and Tracey Watkins, LPN (who worked for years at the CCC before joining our ACTG team).

“One anecdote repeats itself over and over. I am always blown away when I talk to some of our long-time study participants, especially individuals who have volunteered for our ACTG cohort studies. I find it mind boggling that some of them have been enrolled in ACTG studies for 20 years – some of them continuously. I am in awe of any person’s willingness to commit to such a demanding endeavor, and to stick with it for such an extended period of time,” says David Haas, M.D., VT’s CRS leader. “Based on conversations with study participants, I realize that there are two overwhelming reasons why they are willing to commit so much of their lives to research. First, they want to do whatever they can to help other people living with HIV, and know that to volunteer for research studies is to do exactly that. Second, they continue to come for study visits for years and years because they have developed such strong, supportive relationships with research nurses and other staff members at our site.”

The VT CRS team recognizes that they are all together on a noble mission – to improve the longevity and the quality of life of people living with HIV in their local community, nationwide, and around the world. The site also hopes to help to ultimately identify curative therapies for HIV. Their mission has now expanded to include outpatient studies to help identify effective treatments for SARS-CoV-2. The site team also finds being part of the ACTG extremely rewarding because of the privilege of getting to interact frequently with many outstanding investigators, staff members, and community members at other institutions in the U.S. and around the world. Very few people in the world, regardless of their profession, have the privilege of such an experience. 

The Vanderbilt Therapeutics (VT) CRS is actively enrolling HIV-focused studies including A5359 (The LATITUDE Study) and A5379 (the BEe-HIVe study), is about to open A5391 (the Do It study), and is enrolling to ACTG’s COVID-19-focused study A5401/ACTIV-2. They plan to participate in A5383 (the ELICIT study) and other studies as they open. They also continue to follow with participants in A5321 (the HIV Reservoirs Cohort study), A5322 (HAILO), and A5332 (REPRIEVE).

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