News Release

ACTG to make 29 presentations at CROI 2023

Presentations focus on COVID-19; HIV cure, pathogenesis, treatment and long-term complications; tuberculosis; hepatitis C; and contraception

Business Announcement

AIDS Clinical Trials Group

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Los Angeles, Calif. – The AIDS Clinical Trials Group (ACTG), the world’s largest HIV research network whose focus has expanded to include evaluating outpatient treatment for COVID-19, will present four oral presentations, two themed discussions, and 23 poster sessions at the Conference on Retroviruses and Opportunistic Infections (CROI 2022), which will be held February 19-22, 2023 in Seattle, Washington. CROI is the premier global HIV research conference and ACTG’s robust presence at the meeting demonstrates its continued leadership in HIV and related fields.

“The studies the ACTG is presenting at CROI this year represent important advances across the research agenda for the group, including HIV, COVID-19, hepatitis C, and TB, and they demonstrate that after more than 35 years, the ACTG continues to be a leader in research,” said ACTG Chair Judith Currier, M.D., MSc, of the University of California, Los Angeles. “We are especially excited to share insights in eight presentations about COVID-19, which we believe make important contributions to our understanding of SARS-CoV-2. We’re also proud to present findings on a number of long-term complications related to HIV and to highlight important findings in TB, including drug-resistant TB, and hepatitis C. Much of the work presented this year is led by a talented group of emerging investigators engaged with the ACTG. The ACTG remains committed to advancing research in these fields to ultimately improve the lives of people affected by these conditions.”

ACTG presentations are listed below by topic.
 

COVID-19

CHARACTERIZATION OF SINGLE VERSUS DUAL ACTIVE MONOCLONAL ANTIBODIES AGAINST SARS-COV-2 (ACTG 5340; Oral Presentation: Tuesday, February 21, 10:21 am PT, Flex C – Level 2) Manish C. Choudhary, et al.
This study evaluated the viral kinetics and resistance emergence in individuals with COVID-19 treated with mono versus dual-active anti-SARS-CoV-2 monoclonal antibodies. 

 

SAFETY AND EFFICACY OF INHALED INTERFERON-β1A (SNG001) IN OUTPATIENTS WITH COVID-19 (ACTG 5401; Oral Presentation: Tuesday, February 21, 10:29 am PT, Flex C – Level 2) Prasanna Jagannathan, et al.
This study evaluated the safety and efficacy of orally inhaled nebulized interferon-β1a (SNG001) in a phase 2 randomized controlled trial on the ACTIV-2/A5401 platform.

 

SYMPTOM AND VIRAL REBOUND IN UNTREATED COVID-19 INFECTION (ACTG 5401; Oral Presentation: Tuesday, February 21, 11:08 am PT, Flex C – Level 2) Rinki Deo, et al.
Because the natural course of viral and symptom trajectories during COVID-19 have not been well described, this study evaluated the incidence of viral rebound and symptom relapse in untreated individuals with mild-to-moderate COVID-19.
 

POST-ACUTE COVID OUTCOMES: AMUBARVIMAB+ROMLUSEVIMAB VS PLACEBO IN THE ACTIV-2 TRIAL (ACTG5401; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session N1 PASC) Teresa H. Evering, et al.
This study assessed the impact of the SARS-CoV-2 monoclonal antibodies amubarvimab+ romlusevimab (which were highly effective in reducing 28-day hospitalizations and deaths among high-risk adults with mild-to-moderate COVID-19) on late outcomes, including Long COVID.  

 

IMPACT OF COVID-19 AND HOST FACTORS ON THE HUMORAL IMMUNE REPERTOIRE IN TREATED HIV (ACTG 5332; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session D6) Samuel R. Schnittman, et al. 
This study sought to elucidate the mechanisms (including the effects of COVID-19 and host factors on the humoral immune repertoire) that seem to increase the risk for worse COVID-19 outcomes among people living with HIV who are on ART.

 

PLASMA ANTIBODY AND N ANTIGEN STATUS PREDICT OUTCOMES IN OUTPATIENTS WITH COVID-19 (NWCS 540; Poster Presentation: Tuesday, February 21, 2:30 – 4:00 pm PT, Poster Session B7) Nikolaus Jilg, et al.
In response to the critical need for reliable biomarkers of COVID-19 severity and outcomes, this study evaluated associations between anti-Spike IgG and SARS-COV-2 nucleocapsid antigen in plasma with clinical outcomes from outpatients with COVID-19.

 

IMMUNE STATUS AND SARS-COV-2 VIRAL DYNAMICS (ACTG5401; Poster Presentation: Tuesday, February 21, 2:30 – 4:00 pm PT, Poster Session N2) Yijia Li, et al.
People who are immunocompromised are disproportionately affected by severe SARS-CoV-2, but immune compromise is heterogenous, which may impact viral dynamics. This study evaluated the relationship between degrees of compromised immunity, viral shedding, and viral clearance in the absence of COVID-19 therapeutics. 

 

TIXAGEVIMAB/CILGAVIMAB IM AND IV IN SYMPTOMATIC COVID-19: A RANDOMIZED CONTROLLED ACTIV-2 TRIAL (ACTG5401; Poster Presentation: Wednesday, February 22, 2:30 – 4:00 pm PT, Poster Session H8) Rachel Bender Ignacio, et al.  
This study evaluated the safety and efficacy of tixagevimab/cilgavimab, an anti-SARS-CoV-2 monoclonal antibody combination, among outpatients with COVID-19 through both intravenous and intramuscular administration.   

 

Long-term Complications of HIV

SLOWING OR REVERSAL OF DECAY OF INTACT HIV-1 PROVIRUSES OVER TWO DECADES OF ART (ACTG 5321; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session E2) Rajesh T. Gandhi, et al.
This study conducted measurements of intact, defective, and total proviral DNA in people with HIV over the course of two decades of well-documented continuous, virally suppressive ART to identify patterns of intact proviral DNA decay. 

 

PERICORONARY ADIPOSE TISSUE DENSITY AND SUBCLINICAL CORONARY ARTERY DISEASE IN HIV (ACTG 5332; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session L1) Borek Foldyna, et al.
This study compared the relationship between pericoronary adipose tissue density (an index of pericoronary inflammation) to the presence and extent of coronary artery disease among people living with HIV and a control cohort.

 

MUSCLE QUALITY IS ASSOCIATED WITH CORONARY ARTERY PLAQUE & PHYSICAL FUNCTION IN PWH HIV (ACTG 5332; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session L1) Kristine M. Erlandsonet al.
This study evaluated whether paraspinal muscle density and muscle area are associated with cardiac or physical function outcomes in people living with HIV in the REPRIEVE study.

 

CORONARY ARTERY PLAQUE COMPOSITION AND SEVERITY RELATES TO THE INFLAMMASOME IN HIV (ACTG 5332; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session L1) Samuel R. Schnittman, et al. 
The inflammasome is an innate immune system component that regulates the secretion of powerful proinflammatory cytokines and has increased activity in people living with HIV despite ART. This study sought to understand the relationship between inflammasome activation and coronary artery plaque composition and severity.

 

PERFORMANCE OF LDL CHOLESTEROL POLYGENIC RISK SCORE IN INDIVIDUALS WITH HIV INFECTION (ACTG 5332; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session L2) Roger S. Zou, et al. 
Despite coronary artery disease being a leading cause of death among people living with HIV globally, available cardiovascular disease risk predictors underperform among this population. This study sought to better understand whether LDL-C concentration summed as a polygenic risk score would predict LDL-C and coronary artery disease among people living with HIV, as it does in the general population.

 

CMV IGG IS ASSOCIATED WITH MUSCLE FUNCTION BUT NOT QUALITY OR MASS IN PEOPLE WITH HIV (ACTG 5332; Poster Presentation: Tuesday, February 21, 2:30 – 4:00 pm PT, Poster Session M5) Kristine M. Erlandson, et al.
This study examined associations of CMV IgG antibody titers with physical function and muscle quality/quantity in virologically suppressed middle-aged people living with HIV, leveraging REPRIEVE baseline data. 

 

CHANGES IN BODY MASS INDEX WITH INTEGRASE INHIBITOR USE IN REPRIEVE (ACTG 5332;Poster Presentation: Wednesday, February 22, 2:30 – 4:00 pm PT, Poster Session M6) Emma M. Kileel, et al. 
This analysis of the effect of integrase strand transfer inhibitors on body mass index (BMI) was conducted in a large international cohort of people living with HIV enrolled in REPRIEVE, a double-blind randomized trial evaluating the effect of pitavastatin to prevent coronary artery disease among people living with HIV who are at low risk. 

 

LOW CD4 NADIR AT HIV DIAGNOSIS ASSOCIATES WITH INCREASED RISK OF CLONAL HEMATOPOIESIS (ACTG 5332; Poster Presentation: Wednesday, February 22, 2:30 – 4:00 pm PT, Poster Session L4) Romit Bhattacharya, et al. 
While clonal hematopoiesis of indeterminate potential (CHIP, which promotes atherosclerosis) is known to be increased in people living with HIV, it is unknown whether HIV-specific risk factors are associated with CHIP prevalence or CHIP gene distribution. This study sought to better understand these risk factors. 

 

HIV Pathogenesis

SOLUBLE IMMUNOREGULATORY PROTEINS PREDICTIVE FOR COMORBID EVENTS IN PEOPLE WITH HIV (NWCS 411; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session M4) Thomas A. Premeauxet al. 
People living with HIV have an increased risk of morbidity and mortality, partly driven by chronic immune dysfunction despite effective ART. Researchers have previously identified several first-tier immunoregulatory proteins associated with diminished lymphocyte effector function to predict comorbid outcomes in people living with HIV. This study aimed to identify additional predictors of non-AIDS events. 

 

VIRAL AND HOST MEDIATORS OF PERSISTENT LOW-LEVEL VIREMIA (NWCS 371; Oral Presentation: Tuesday, February 21, 10:21 am PT, Ballroom 1 – Level 5) Abbas Mohammadi, et al.  
The mechanisms behind persistent, or non-suppressible, low-level HIV viremia (which can occur in people living with HIV despite adherence to ART and in the absence of significant drug resistance) remain unclear. This study sought to elucidate contributing factors.

 

SEX DIFFERENCES IN CYTOKINE DYNAMICS IN PEOPLE WITH HIV ON ART DURING AGING (NWCS 443; Poster Presentation: Wednesday, February 22, 2:30 – 4:00 pm PT, Poster Session B4) Alan Wells, et al.
This study investigated immunologic mechanisms underlying the fact that women undergoing reproductive aging have a progressive increase in inducible HIV reservoirs, in sharp contrast to the steady decline in the reservoir size in men. 

 

Tuberculosis

TB OUTCOMES IN PEOPLE LIVING WITH HIV: AN INTEGRATIVE DATA ANALYSIS OF PHASE 3 TRIALS (ACTG 5349Themed Discussion: Monday, February 20, 1:35 pm PT, Ballroom 1 – Level 5) Rob C. van Wijk, et al. 
This study sought to understand risk factors unique to people living with HIV that are responsible for high rates of TB-related outcomes by performing an individual patient data meta-analysis.

 

HIGH-DOSE ISONIAZID EARLY BACTERICIDAL ACTIVITY AGAINST DRUG-RESISTANT TUBERCULOSIS (ACTG 5312; Poster Presentation: Tuesday, February 21, 2:30 – 4:00 pm PT, Poster Session O3) Kamunkhwala Gausi, et al.
This study evaluated both the optimal dose of and the efficacy of high-dose isoniazid (INH) against drug-resistant tuberculosis, as they have not yet been established.

 

EFFECTIVENESS OF DOLUTEGRAVIR IN PEOPLE ON RIFAMPIN-BASED TUBERCULOSIS TREATMENT (ACTG5381; Poster Presentation: Tuesday, February 21, 2:30 – 4:00 pm PT, Poster Session O3) N. Sarita Shah, et al. 
This prospective, observational study evaluated the effectiveness of dolutegravir in participants taking rifampin-based treatment.

 

MONOCYTE-TO-LYMPHOCYTE RATIO AND HEMOGLOBIN LEVEL TO PREDICT TB AFTER ART INITIATION (DR067; Poster Presentation: Wednesday, February 22, 2:30 – 4:00 pm PT, Poster Session O4) Sivaporn Gatechompol, et al.
In the interest of identifying a prediction test that accurately identified people living with HIV who are at risk of active TB, this study evaluated the ability of routinely collected monocyte to lymphocyte ratio and hemoglobin level to predict active TB development. 

 

HIV Treatment

PROJECTED BENEFITS OF LONG-ACTING ART IN PWH WITH VIREMIA DESPITE PRESCRIBED ORAL ART (CEPAC; Themed Discussion: Tuesday, February 21, 1:40 pm PT, Flex C – Level 2) Wanyi Chen, et al. 
This study projected the clinical impact of providing long-acting injectable antiretroviral therapy (ART) with wrap-around social services for people living with HIV who were previously unable to achieve viral suppression on oral ART. 

 

PHENOTYPIC SUSCEPTIBILITY TO VRCO7-523LS AND ITS CORRELATES IN THE ACTG A5357 STUDY (ACTG 5357; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session I2) Babafemi O. Taiwo, et al. 
This study sought to establish predictors and correlates of susceptibility to VRCO7-523LS, a broadly neutralizing anti-HIV-1 monoclonal antibody being studied in combination with long-acting cabotegravir to treat HIV. 

                       

Contraception

ACCEPTABILITY OF EMERGENCY CONTRACEPTION IN ACTG A5375 (ACTG 5375; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session X1) Elizabeth Barr, et al. 
In order to address the barrier that contraceptive requirements in clinical trials can pose for people capable of pregnancy, this study assessed the acceptability and practicality of emergency contraception. 

 

GENETICS OF HIV AND TB DRUG INTERACTIONS WITH LEVONORGESTREL EMERGENCY CONTRACEPTION (ACTG 5375; Poster Presentation: Tuesday, February 21, 2:30 – 4:00 pm PT, Poster Session G2) Nana Agyemang, et al.
This study characterized the pharmacogenetics of drug interactions between levonorgestrel (emergency contraception), efavirenz, and rifampin. 

 

Hepatitis C

SVR12 OUTCOMES FOR NOVEL HCV GENOTYPE/SUBTYPES WITH SOF/VEL IN MINMON STUDY (ACTG 5360 Poster Presentation: Tuesday, February 21, 2:30 – 4:00 pm PT, Poster Session J2) Win Min Han, et al. 
This study characterized the response to direct antiviral agents for rare or novel HCV subtypes and their sustained virologic response outcomes.

 

HIV Cure Research

STABILITY AND INSTABILITY OF THE CELLULAR HIV RESERVOIR AFTER REBOUND DURING THERAPY INTERRUPTION (ACTG 5340; Poster Presentation: Monday, February 20, 2:30 – 4:00 pm PT, Poster Session E2) Vincent H. Wu, et al. 
Recent studies during treatment interruption in passive immunotherapy trials have demonstrated that reservoir reseeding can coincide with viral rebound. This study sought to understand whether reseeding is associated with compositionally distinct cellular populations.

 

About the ACTG
Founded in 1987, the AIDS Clinical Trials Group (ACTG) was the world’s first HIV research network. Funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and collaborating NIH institutes, the ACTG conducts groundbreaking studies to improve the treatment of HIV and its complications, including tuberculosis and viral hepatitis; reduce new infections and HIV-related illness; and advance new approaches to prevent, treat, and ultimately cure HIV in adults and children. ACTG investigators and research units in 15 countries serve as major resources for HIV/AIDS research, treatment, care, and training/education in their communities. ACTG studies have helped establish current paradigms for managing HIV disease, and have informed HIV treatment guidelines, resulting in dramatic decreases in HIV-related mortality worldwide. 


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