Press Releases and Announcements
The ACTG congratulates the A5386 study team as the first participant was randomized on January 13! A5386 is a phase 1 HIV cure study evaluating two promising therapies. A5386 will study whether N-803 (a clinical-stage biologic also called Anktiva™) can control HIV alone or together with combination broadly neutralizing antibodies (bNAbs) after participants stop their antiretroviral therapy (ART) and they are carefully monitored. Read more about the study HERE.

The ACTG is happy to announce the publication of the primary manuscript for A5360 (MINMON), "A Minimal Monitoring Approach for the Treatment of Hepatitis C Virus Infection: A Phase 4 Open-label, Single-arm Trial", in The Lancet Gastroenterology and Hepatology! The study found that the approach with sofosbuvir–velpatasvir treatment was safe and achieved SVR comparable to standard monitoring observed in real-world data. Coupled with innovative case finding strategies, this strategy could be crucial to the global Hepatitis C virus elimination agenda. Congratulations to the team & study authors! You can read the full manuscript HERE.

Coming Up: The ACTG attends CROI 2022! Be on the lookout for more information and follow along on out social media channels. 

A Reflection on National Black HIV/AIDS Awareness Day (February 7)
By Orbit Clanton, GCAB Co-Chair

In the United States, February has been designated as Black History month and February 7th is National Black HIV/AIDS Awareness Day (NBHAAD). This observance is an opportunity to get the word out about HIV testing, education, treatment, and community involvement. It is also an opportunity to remind people that HIV is both preventable and treatable. The HIV epidemic in the United States has a disproportionate impact on Black people and in 2022, we are again observing NBHAAD in the midst of the COVID-19 pandemic, which has inequitably harmed Black communities. On NBHAAD and every day, public health sectors must come together to prioritize the health concerns of Black people.
One contributor to the inequities in both HIV and COVID-19 among Black people is medical mistrust. The impacts are clear as data shows that from 2014 to 2018, HIV rates among white cis men fell at twice the rate of Black cis men. These examples of widespread inequities in HIV prevention and treatment are clear calls to public health officials, researchers, policymakers, and community leaders everywhere to take action against the systematic barriers to prevention and treatment that continue to drive today’s HIV epidemic.
Throughout the years, Black people have and continue to face barriers for HIV clinical trials participation, even when research opportunities are available at their clinics. The ACTG was one of the earliest networks to release a statement of solidarity with communities of color. It has implemented new clinical trial enrollment tools and  strategies that promote greater representation of people of color in HIV research. Nevertheless, continued efforts to increase participant diversity in HIV studies are needed.

As the ACTG Global Community Advisory Board Co-Chair and a Black HIV positive American, my role in raising awareness of HIV among Black Americans is to be as visible, outspoken, and honest about the ACTG’s goals and mission. I also do my best to educate people, especially the Black community, about all things HIV related to clinical trials.
In conclusion, despite a high need for focused resources, the public health system has too often left behind Black people in services and outreach designed to reduce the transmission of HIV. The social and economic factors that have an impact on HIV outcomes in Black communities are common across all of public health and have been especially apparent during the COVID-19 pandemic. First, I call upon everyone to bust stigma surrounding HIV by better disseminating scientific facts and data about HIV to the most affected communities. Second, I call on local health departments across the county to adopt comprehensive HIV prevention, testing, and treatment strategies that center communities of color. Lastly, I call on national leadership to increase funding for HIV treatment research. Ending the HIV epidemic is not one-strategy-fits-all and public health departments need to partner with communities to understand and collaboratively address the health needs of Black people.
I thank the ACTG for being the premier global HIV clinical research network that recognizes and acknowledges that NBHAAD still matters because it keeps the conversation going not only in the Black community, but in all communities.

Moreover – I thank the level of engagement with communities of color within the ACTG network. It demonstrates both nationally and globally a true commitment to the partnership between network leadership and communities of color.

Better Assessing Heart Disease Risk and Heart Health Among People with HIV
As survival among people living with HIV has improved, heart disease has become a leading cause of illness and death. While careful assessment of risk factors and health behaviors to guide medication use and lifestyle changes can reduce risk and prolong life, the accuracy of otherwise well-established heart disease risk scores has not been tested among people living with HIV. Similarly, health behaviors have not been well-categorized among people living with HIV, nor do we know how they relate to risk.
A5332 (REPRIEVE) included 7382 participants whose average age was 50, and among whom 31% were women.
REPRIEVE used the most commonly used heart disease risk score, the Pooled Cohort Equations (PCE), which uses age, sex, race, high blood pressure, diabetes, high LDL cholesterol, and smoking to predict risk. In REPRIEVE, the median score was 4.5%, which means that participants had a less than 5% chance of having a heart disease event (like a heart attack) over the next 10 years. Almost a third of participants had a risk score less than 2.5%.
Investigators also used Life’s Simple 7, which uses measures of smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and glucose to evaluate heart health. The median score was 9 (out of a possible 14). One third of participants had two or fewer ideal behaviors; only 105 (1.4%) participants had five or more ideal behaviors.
Importantly this study elucidated that the most commonly used heart disease risk score did not reflect common unhealthy behaviors among people living with HIV, including poor diet, high body mass index, and low physical activity. These behaviors were present across participants, regardless of their level of heart disease risk, suggesting that lifestyle interventions may be important to prevent heart disease among people living with HIV, and should be used to complement conventional treatment.

Douglas, P., Umbleja, T., et. al. Cardiovascular Risk and Health Among People With Human Immunodeficiency Virus (HIV) Eligible for Primary Prevention: Insights From the REPRIEVE Trial,

Assessing the Relationship Between Greater Muscle Fat and Lower Muscle Area and Inflammation and Immune Activation after Starting ART
Research has demonstrated that starting antiretroviral therapy (ART) is associated with an increase in skeletal muscle, though it tends to be quite fatty. A5260s explored whether the gains in skeletal muscle area or the amount of fattiness were associated with markers of inflammation and immune activation. Individuals living with HIV were randomized to start treatment with raltegravir, ritonavir-boosted atazanavir, or darunavir, in combination with tenofovir disoproxil fumarate/emtricitabine. This substudy included 222 participants and analyzed abdominal computed tomography (CT) scans at baseline and week 96 for muscle amount and fattiness and used previously measured markers of inflammation and immune activation. At baseline, greater muscle fat and lower muscle area were associated with higher inflammation and immune activation. From baseline to week 96, a greater increase in muscle fat and decrease in muscle area were associated with greater increases in inflammation and immune activation. Whether these muscle characteristics are the cause or the consequence of inflammation cannot be determined within this study. Future studies will need to explore the impact of these changes in muscle and inflammation on physical function and other complications, including cardiometabolic risk.

Kousari A, Moser C, Olefsky M, Brown TT, Currier JS, McComsey GA, Scherzinger A, Stein JH, Lake JE, Erlandson KM. Poorer Muscle Quality and Quantity with ART Initiation is Associated with Greater Inflammation and Immune Activation. J Acquir Immune Defic Syndr. 2021 Aug 5. doi: 10.1097/QAI.0000000000002776. Epub ahead of print. PMID: 34326283.
Site Spotlight
Weill Cornell Chelsea CRS, New York City, New York, USA


Weill Cornell Chelsea CRS has been part of the ACTG since April 2011, has a team of 20 people conducting clinical research, and is participating in more than 12 ACTG studies. In addition to their clinical team, they have administrative and pharmacy staff members that are fundamental to helping the site run smoothly. Some of the staff members have been with the site for more than 20 years! There have been recent changes in leadership as Kristen Marks, MD, took over as CRS Leader from Tim Wilkin, MD, MPH, and Shaun Barcavage, NP, took over as study coordinator from Todd Stroberg, RN. Together, they hope to continue to expand the research site while maintaining the high standards and sense of community established by their predecessors.

The team dynamic at the Weill Cornell Chelsea CRS can best be described as vibrant, with a lot of friendly faces every day. The site cultivates a strong sense of teamwork where everyone is open and willing to pitch in and support each other in achieving their goals. Each team member is dedicated to their work, while also maintaining an enthusiasm for curiosity and knowledge. The site is also an important research presence in the heart of New York City. The environment is a cross between a community clinic and a major academic medical center. Their participants can feel comfortable receiving care in their community, while also feeling proud that they are contributing to important clinical research.

Transitioning back to seeing participants face-to-face and enrolling again in their non-COVID-19 ACTG studies has been a major milestone for not only the site’s staff, but their participants as well. As one of the early epicenters of the COVID-19 pandemic, the site had to quickly pivot their operations to remote visits. This operational shift required the staff to change not only how they conduct participant visits, but also data entry and monitoring visits. The site is happy to have been able to maintain high retention rates and data scores throughout this transition, during which time, the site hired new clinicians and supporting staff. It was meaningful for participants to meet the new staff and put a face to the name when they returned in person.

Although the site may not see the immediate results of their research , they know that all of these small actions add up to a positive impact on peoples’ lives. “Contributing to scientific knowledge that has translated into improving the quantity and quality of life of people living with HIV has been most meaningful of my work with the ACTG.”, said Marshall Glesby, MD, PhD. This was most evident during National HIV/AIDS Awareness Day, where the site was able to head individuals speak about the benefits they have received from treatments that were approved because of ACTG studies. “The addition of HIV cure research to the network's scientific agenda, made possible by the completion of pivotal ACTG studies that improved treatment outcomes and tolerability for people living with HIV, has been an important milestone for the ACTG”, said Kristen Mark, MD, CRS Leader.

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Awareness Days:
- February 7: National Black HIV/AIDS Awareness Day

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