Press Releases and Announcements
The ACTG congratulates the recently elected chairs and vice chairs of the Transformative Science Groups (TSGs), the Collaborative Science Groups (CSGs), and the Community Scientific Subcommittee (CSS)!
  • Reservoirs Remission and Cure TSG:
    • Chair: Marina Caskey, M.D.
    • Vice Chair: Katharine Bar, M.D.
  • Tuberculosis TSG:
    • Chair: Kelly Dooley, M.D., Ph.D.
    • Co-vice Chairs: Payam Nahid, M.D., M.P.H. and Vidya Mave, M.D., T.M., M.P.H.
  • Comorbidities TSG:
    • Chair: Netanya Utay, M.D.
    • Vice Chair: Kristine Erlandson, M.D.
  • Hepatitis TSG:
    • Chair: Debika Bhattacharya, M.D.
    • Vice Chair: Arthur Yu-shin Kim, M.D.
  • Women's Health CSG:
    • Chair: Rosie Mngqibisa, M.B., Ch.B., M.P.H.
    • Vice Chair: Risa Hoffman, M.D., M.P.H.
  • Neurology CSG
    • Chair: Beau Ances, M.D., Ph.D., M.Sc.
    • Vice Chair: Felicia Chow, M.D.
  • CSS
    • Co-Chairs: Martha Tholanah and Scovia Aseru

Seeking study candidates for A5404

A5404, “SARS-CoV-2 Immune Responses after COVID-19 Therapy and Subsequent Vaccine” is currently enrolling participants from ACTIV-2/A5401 who received an investigational therapy or its comparator and persons without prior history of SARS-CoV-2 infection (non-A5401 participants). A5404 aims to evaluate how prior investigational therapy for COVID-19 versus comparator (placebo or active comparator) affects COVID-19 vaccine response. Note that non-A5401 persons must be COVID-19 vaccine naïve to enroll. Participants will receive the Moderna vaccine through the study. A5404 is open to select US clinical research sites that are participating in A5401. Sites include Chapel Hill CRS, Penn Therapeutics CRS, Puerto Rico AIDS Clinical Trials Unit CRS, Rush University CRS, University of California, San Diego Anti-Viral Research Center CRS, University of California San Francisco HIV/AIDS CRS, and Washington University Therapeutics CRS. Sites participating in A5404 may work with A5401 non-ACTG sites for referrals. For more information visit: A5404: SARS-CoV-2 Immune Responses after COVID-19 Therapy and Vaccine – ACTG Network

Identifying People During the Acute and Early Phases of HIV

Research suggests many potential benefits to starting antiretroviral therapy (ART) within the first few days or weeks after HIV has been acquired. Studies that enroll participants with early HIV or after early treatment initiation are especially important to test potential strategies to control HIV that don’t depend on lifelong ART. However, it is logistically difficult to diagnose HIV and start ART so soon after acquisition. A5354 attempted to do this at 30 ACTG sites in the Americas, Africa, and Southeast Asia. Sites used any of six criteria to identify people with very early HIV, including combinations of viral load testing, antibody testing, and antigen testing. Researchers utilized new ways of looking at how strongly positive some of these tests were (the signal-to-cutoff ratio) to determine how recently HIV was acquired. The study enrolled 195 participants and started 171 (87.7%) on ART on the day of enrollment and 24 (12.3%) the next day. After enrollment, centralized testing confirmed that 188 (96.4%) participants had acute or early HIV. Four (2.0%) participants had acquired HIV long ago and were now in the chronic phase of HIV while three (1.5%) were found not to have HIV, discontinued ART, and were withdrawn from the study. The signal-to-cutoff ratio correctly identified 99 of 122 (81.2%) participants who were in specific stages of acute or early HIV (Fiebig stages 2-4) with no false-positive results. Because some of the inclusion criteria in A5354 did not require an HIV viral load (which may take several days or more to produce a result), they may be helpful for clinicians and researchers who are trying to accurately diagnose acute or early HIV and start ART quickly. 

How quickly one needs to start HIV treatment is still being investigated. There are no data demonstrating differences in clinical outcomes in starting HIV treatment on the same day of diagnosis versus the within 2-4 weeks of diagnosis.  There is broad consensus that starting therapy as soon as possible is beneficial for the individual, may prevent further transmission of HIV and waiting too long (more than 8-12 weeks) can result in illness. Some of the barriers to initiating treatment on the same day of diagnosis is ensuring that the individual is confirmed to have HIV and starting therapy that is likely to work (meaning no resistance to treatment). This study helps to begin to identify people early on with HIV and allow for more prompt initiation of treatment.

Trevor A Crowell, Justin Ritz, Robert W Coombs, Lu Zheng, Joseph J Eron, John W Mellors, Joan Dragavon, Gert U van Zyl, Javier R Lama, Kiat Ruxrungtham, Beatriz Grinsztejn, Roberto C Arduino, Lawrence Fox, Jintanat Ananworanich, Eric S Daar, AIDS Clinical Trials Group A5354/EARLIER (Early ART to Limit Infection and Establishment of Reservoir) Study Team, Novel Criteria for Diagnosing Acute and Early Human Immunodeficiency Virus Infection in a Multinational Study of Early Antiretroviral Therapy Initiation, Clinical Infectious Diseases, Volume 73, Issue 3, 1 August 2021, Pages e643–e651

Understanding latency among people living with HIV in low- and middle-income countries
Many studies from high-income countries have shown that HIV can linger in the body during HIV treatment, meaning that it is not completely eliminated from the body. However, there have been few reports from low- and middle-income countries (LMIC) investigating this phenomenon. NWCS425 aimed to determine how often HIV lingers in the body among individuals achieving very low levels of HIV while on treatment in LMIC. Researchers also conducted a comparison of the rate at which very low levels of HIV remains in the body between individuals in LMIC and the United States. The last available sample among participants living with HIV less than 400 copies/mL for at least three years from A5175 and A5208 were tested by using the method known as the HMMCgag single copy assay (SCA). Detectable HIV was defined as having ≥1 copy/mL. The study included 320 participants, including 246 (77%) from LMIC and 74 (23%) from the United States. NWCS425 found that 57 percent of all participants had HIV remaining in their body during HIV treatment. This percentage was similar among participants from LMIC (59%) and the United States (51%). The study also found that the only factor associated with HIV remaining in the body was more copies of HIV before beginning HIV treatment. This important finding indicates that the sooner antiretroviral treatment is initiated, the less HIV will remain in the body as latent reservoir. In addition, this study confirms that HIV reservoirs are similar regardless of where you live in the world. These results may help us design future cure studies that can be conducted throughout the world.

Gatechompol, S., Zheng, L., Bao, Y., Avihingsanon, A., Kerr, S. J., Kumarasamy, N., Hakim, J. G., Maldarelli, F., Gorelick, R. J., Welker, J. L., Lifson, J. D., Hosseinipour, M. C., Eron, J. J., & Ruxrungtham, K. (2021). Prevalence and risk of residual viremia after ART in low- and middle-income countries: A cross-sectional study. Medicine100(35), e26817.

Participant perspectives and experiences entering an intensively monitored antiretroviral pause

Analytical treatment interruptions (ATIs) have become a common feature of HIV cure-related trials but there are currently no biomarkers (or signals in the blood) that can accurately predict when HIV will return during an ATI. Co-led by Drs. Jonathan Li (Brigham and Women's Hospital, Boston) and Davey Smith (University of California, San Diego), A5345 study was designed to identify biomarkers that could predict viral rebound. The study included a socio-behavioral research component led by Dr. Karine Dubé of UNC-Chapel Hill, in collaboration with A5345 community representatives Liz Barr and David Palm.
A5345 showed that most participants perceived societal-level benefits of advancing HIV cure research, as well as personal-level benefits, such as the opportunity to learn about the body’s response to the ATI. Further, most participants demonstrated a detailed understanding of the study. However, approximately 20 percent  of A5345 study participants did not report any research risks involved despite these being presented during the informed consent process. Common concerns, in about four in five participants, were related to the ATI – including CD4+ cell count decreases, becoming detectable for HIV, and developing acute retroviral syndrome.
These results underscore the importance of considering how research risks are relayed and the perceived benefits of participation (both physical and psychological) from participants’ perspectives. Key messages pertaining to study-related risks may need to be clarified and reiterated periodically throughout follow-up in HIV cure-related studies involving ATIs. The importance of assessing participants’ perceptions and experiences over time in HIV cure-related studies is increasingly recognized (rather than one-time assessments). The investigative team will soon share results from the A5345 follow-up socio-behavioral assessments. Methods and results from the ACTG A5345 socio-behavioral component are informing the design of participant-centered measures as part of extended ATI trials in the ACTG and at UCSF.

This is a very important study confirming that informed consent is a challenging process. It emphasizes the need to continue to explain research studies to participants and obtain ongoing informed consent. Most researchers and study participants agree that consents are hard to understand and too long. The investigators highlight the need to improve our consent process so that participants understand the risks and are able to make informed decisions about study participation.

Diepstra KL, Barr L, Palm D, et al. Participant Perspectives and Experiences Entering an Intensively Monitored Antiretroviral Pause: Results from the AIDS Clinical Trials Group A5345 Biomarker Study. AIDS Res Hum Retroviruses. 2021;37(6):489-501. doi:10.1089/AID.2020.0222
Investigator Spotlight
Iván C. Balán, PhD, Florida State University

Iván C. Balán, Ph.D. is a licensed clinical psychologist and a Research Professor at the Center for Translational Behavioral Science at the Florida State University (FSU) College of Medicine. He recently transitioned to FSU from the Columbia University Medical Center, where he worked for the past 25 years and was most recently an Associate Professor of Medical Psychology (in Psychiatry) at the Columbia University Vagelos College of Physicians and Surgeons and a Research Scientists at the HIV Center for Clinical and Behavioral Studies. 

Iván was born in Santa Clara, Cuba and came to the United States with his family in 1974 after spending two years in Spain. They settled in Union City, NJ (the New Jersey side of the Lincoln Tunnel), which had a large Cuban immigrant population and lived there until he moved to the NJ burbs in 2005. Little did he know how important living in such a vibrant Latino community would be for his career, enabling him to remain fully bilingual and bicultural and sparking his professional interest in culture and mental health. He began his career practicing psychotherapy at what is now the Lucy A. Wicks Clinic for HIV Mental Health at the New York-Presbyterian Hospital and became involved in research shortly thereafter.  In 2002, he transitioned fully to research and for many years split his time between clinical research at the Anxiety Disorders Clinic of the New York State Psychiatric Institute and HIV research at the HIV Center. At the Anxiety Disorders Clinic, he saw patients and developed and implemented numerous Motivational Interviewing-based interventions as part of NIH-funded studies aimed at improving adherence and linkage to care among a broad range of patient populations, including Latinos with depression, individuals with substance use and mental health disorders, and individuals with gambling disorders. In 2012 he began to work with the Microbicides Trials Network as part of MTN-017 to develop, implement, and monitor counseling fidelity (implementing counseling as intended) to support the use of a rectal microbicide and oral PrEP among men who have sex with men and transgender women in Peru, Thailand, South Africa, and Peru. Based on the success of this work, he was asked to implement the same process to support the use of the dapivirine vaginal ring in the HOPE Study, an open-label extension study conducted in Uganda, Malawi, South Africa, and Zimbabwe. Most recently, he is conducting this work as part of the Deliver and B-Prepared studies, which compare the safety of the dapivirine ring and oral Truvada among pregnant and breastfeeding women in sub-Saharan Africa. His other lines of research focus on HIV self- and partner-testing using at home HIV and syphilis tests and on addressing mental aspects of HIV prevention and treatment. 

Within the ACTG, Iván is the Vice Chair of the new Behavioral Science Subcommittee, working alongside the Chair, Jane Simoni, Ph.D. He is excited about the opportunities to contribute to ACTG trials through behavioral science, which he views as a continuation of the work he has done with the MTN over the past nine years.  

A recent transplant to Florida, Iván lives in Sarasota, Florida with his husband, Donato. They enjoy the beach, the vibrant arts community in Sarasota, cooking and entertaining….and not having to shovel snow.        
Site Spotlight
UCLA CARE CRS, Los Angeles, California, USA

The UCLA CARE CRS, located in Los Angeles, California, has been making contributions to the scientific achievements of the ACTG since 1986. The site is currently participating in 16 ACTG clinical trials: A5321, A5359, A5357, A5377, A5368, A5379, A5401, A5404, A5386, A5391, A5128, A5322, A5332, A5333s, A5361s, A5366, as well as HVTN 136/HPTN 092, HVTN 505-VISP, HPTN 083, and several industry-sponsored studies.
Over the past 19 months, the pandemic has introduced many challenges to the work carried out at the UCLA CARE CRS. Still, the CRS staff has not only persevered but thrived, creating many fond memories with participants, community members, and one and another. “As a coordinator for ACTIV-2, it has been such a rewarding experience working with UCLA CARE Center, says Samantha Fortier. “I have felt that I have made a small contribution to science. Through this past year, the ACTIV-2 participants and I have created a bond.” “It would get emotional when participants reflect on their experiences. The participants who were part of the first agent to be studied in ACtIV-2 would say they are happy they are feeling better but sad to say goodbye to our team at their last study visit. As I reflect, it was meaningful for me because the research team and the participants in ACTIV-2 worked so hard as a team during a frightening time to find potential treatments.”
“As an outreach coordinator, I find it greatly satisfying and rewarding to offer populations at risk of acquiring HIV and those living with HIV access to cutting-edge clinical trial research,” says Freddy Favela. “As a public health advocate, my passion lies in providing new opportunities to disenfranchised communities. I hope to reduce the transmission of infectious diseases through health education and outreach, thereby addressing the social determinants of health and improving population health.”
“Our work on ACTG trials has the potential to make a profound impact on the well-being of people living with HIV -- one of the most stigmatized and vulnerable groups in society,” says David Choi, a study coordinator at the CRS. “I am inspired by knowing that the results of these trials can make a difference in how people living with HIV are ‘treated’ (both medically and by society) and by the ultimate pursuit of a cure for HIV.”
Even with the serious nature of the work carried out at the UCLA CARE CRS, there are always plenty of laughs to go around. Melinda Kuo, a data manager at the CRS, enjoys overseeing the annual CARE CRS croquet match, after which the team celebrates with cupcakes from local bakery Sprinkles Cupcakes; the CARE croquet champion gets to proudly display a Justin Bieber figurine on his or her desk for the year
. During particularly challenging weeks, the CRS team also enjoys the impromptu pizza party or bagel breakfasts provided by site leadership with the goal of acknowledging the tremendous accomplishments of the team, even in the setting of multiple complexities.
“While there have been many meaningful moments in ACTG history, one of the most important milestones was expanding clinical trial sites to include a robust network of international sites, where coinfections like viral hepatitis and tuberculosis are prevalent”, said Dr. Debika Bhattacharya.
Moving forward, the UCLA CARE CRS looks forward to starting five new ACTG protocols in the near future: A5383, A5355, A5405, A5394, and A5364. The CRS also continues to conduct HPTN, HVTN (protocol specific), and CoVPN studies leveraging ancillary locations on campus and throughout the community, and partners with sister CRSs in our CTU at UCLA Vine Street, Harbor-UCLA, Hospital Nossa Senhora da Conceicao in Porto Alegre, Brazil, and Fundacion Huesped in Buenos Aires, Argentina.


Licet Garcia was recently endorsed as the new ACTG Executive Director by the ACTG Executive Committee. Licet is grateful for Alexis Sexton’s mentorship and continued support during this transition. Licet recently served as the LOC Finance Manager. Prior to taking on the Finance Manager role, she served as the Business Manager for the UCLA CTU and helped with the planning of the transition of the LOC from Brigham and Women's Health Therapeutics CRS to UCLA.

Outside of the ACTG, Licet is currently working on obtaining her MBA from Washington State University and expects to graduate in the spring of 2022. She also enjoys hiking during the weekends with her husband.
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