University of California, Los Angeles (UCLA), Health Sciences

ACTG to Present 24 New Studies at CROI 2021

Presentations Focus on HIV Cure; COVID-19; TB, Hepatitis C, and Other Co-Morbidities; Contraception; Adherence; and Resistance

Newswise — The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, will present four oral and 20 scientific spotlight sessions at the Conference on Retroviruses and Opportunistic Infections (CROI 2021) held virtually, March 6-10. CROI is one of the premier global HIV research conferences and ACTG’s robust presence at the meeting demonstrates its continued leadership in HIV and related fields.

“The ACTG has a rich history leading wide-reaching and paradigm-shifting research on HIV and its comorbidities and in the last year we have extended that to include leadership in COVID-19 treatment research,” said ACTG Chair Judith Currier, M.D., MSc, of the University of California, Los Angeles. “ACTG studies being presented at CROI offer insights into HIV cure, COVID-19 among non-hospitalized patients, tuberculosis, hepatitis C, contraception, adherence, resistance, and co-morbidities in people living with HIV.” 

ACTG presentations are listed below by topic. 

HIV CURE

NON-INVASIVE PLASMA GLYCOMIC AND METABOLIC BIOMARKERS OF POST-TREATMENT CONTROL OF HIV (NWCS 482; Oral Session: Wednesday, March 10, 11:15am – 1:15pm EST) Leila B. Giron, et al.

Non-invasive biomarkers that predict HIV remission after antiretroviral therapy interruption are urgently needed. NWCS 482 sought to identify non-invasive biomarkers with functional significance that have the potential to predict the duration and probability of viral remission after treatment interruption.

 

MATHEMATICAL MODELING IDENTIFIES PREDICTORS OF POST-TREATMENT CONTROL IN CURE TRIALS (DR 056; Science Spotlight) Gesham Magombedze, et al.

The identification of early predictors of post-treatment control could improve the efficiency of analytical treatment interruptions (ATI) in cure trials and increase participant safety by limiting time off ART in non-controllers. DR056 leveraged available data from ACTG and Gilead Sciences ATI studies to identify early predictors of viral control.

 

AUTOLOGOUS NEUTRALIZING ANTIBODIES INCREASE WITH EARLY ART AND SHAPES HIV REBOUND (NWCS 380; Science Spotlight) Elmira Esmaeilzadeh, et al.

Early initiation of ART alters viral rebound kinetics after treatment interruption and may play a role in reducing the barrier to HIV remission. NWCS 380 evaluated whether autologous neutralizing antibody responses could develop in the setting of early-ART initiation and investigated their role in treatment interruptions.

 

ASSOCIATION OF IMMUNE MARKERS TO TIME TO REBOUND DURING HIV TREATMENT INTERRUPTION (ACTG 5345; Science Spotlight) Bernard Macatangay, et al.

Understanding factors that affect viral rebound timing during ART interruption will accelerate efforts toward inducing sustained HIV remission. ACTG 5345 evaluated whether immunologic parameters prior to treatment interruption can predict time to rebound in individuals interrupting ART in a highly monitored setting.

 

resting AND ACTIVATED cd4+ t cells BOTH have Silent and active HIV proviruses in vivo (ACTG 5341; Science Spotlight) Jennifer Groebner, et al.

Despite clinically effective ART, HIV-infected T cells survive and undergo cellular proliferation. ACTG 5341 hypothesized that the minority of T cells that express unspliced HIV RNA are in an activated state, while the majority of cells with transcriptionally silent proviruses are in a resting state.

 

MONOCYTE SUBSETS AFTER LONGTERM ART AND ASSOCIATIONS WITH MEASURES OF HIV PERSISTENCE (ACTG 5321; Science Spotlight) Bernard Macatangay, et al.

Several studies have investigated the role of monocytes in HIV infection, specifically in HIV-associated chronic inflammation. Because it remains unclear how monocytes correlate with measures of HIV persistence in individuals on long-term suppressive ART, A5321 evaluated monocyte subsets among this population.

 

COVID-19

SYMPTOM OUTCOME MEASURES FOR OUTPATIENT COVID-19 PHASE 3 TREATMENT TRIALS (ACTG 5401; Science Spotlight) Kara Chew, et al.

Symptom-based outcome measures should be considered for primary efficacy assessment in outpatient phase 3 COVID-19 treatment trials. ACTG 5401 analyzed potential measures utilizing patient-reported outcomes in the ACTIV-2 (an outpatient COVID-19 treatment study) participant diary. 

 

SARS-COV-2 RNA LEVELS CORRELATE WITH SYMPTOM DURATION BUT NOT SEVERITY IN OUTPATIENTS (ACTG 5401; Science Spotlight) Kara Chew, et al.

ACTG 5401 aimed to elucidate the relationship between nasopharyngeal SARS-CoV-2 RNA, demographics, and symptom characteristics in non-hospitalized people with COVID-19.

 

TUBERCULOSIS

ADVERSE PREGNANCY OUTCOMES AMONG HIV-INFECTED WOMEN EXPOSED TO ISONIAZID PREVENTIVE THERAPY IN THE BRIEF-TB TRIAL (ACTG 5279; Oral Session: Wednesday, March 10, 11:15am – 1:15pm EST) Amita Gupta, et al.

Isoniazid preventive therapy (IPT) is a key strategy for reducing TB and death among people living with HIV but has been associated with increased composite adverse pregnancy outcomes. ACTG 5279 assessed adverse pregnancy outcomes among women exposed to IPT in a secondary analysis of the BRIEF-TB trial, which demonstrated non-inferiority of one-month of IPT versus nine months.

 

SERUM MARKERS AND INTEGRATIVE MULTI-OMICS OF TB DIAGNOSIS IN ADVANCED HIV (NWCS 414; Science Spotlight) Sonya Krishnan, et al.

Tuberculosis (TB) accounts for a large burden of morbidity and mortality among people living with HIV and conventional diagnosis methods have lower sensitivity among that population. Because novel high-throughput diagnostics may advance our insights into subclinical and difficult to diagnose TB (especially in very advanced HIV), NWCS 414 evaluated a variety of screening mechanisms.

 

HEPATITIS C

THE KISS (KEEP IT SIMPLE AND SAFE) APPROACH TO HCV TREATMENT: PRIMARY OUTCOMES FROM THE ACTG A5360 (MINMON) STUDY (Oral Session: Tuesday, March 9, 11:15am – 1:15pm EST) Sunil Solomon, et al.

To achieve the goal of global HCV elimination by 2030, 80% of the ~71 million people with chronic HCV infection will need to be treated, requiring that treatment delivery be simplified without compromising efficacy or safety. COVID-19 has further highlighted the need for novel models of healthcare delivery that minimize in-person patient-provider contact. ACTG A5360 evaluated the safety and efficacy of a minimal monitoring (MINMON) approach to HCV therapy in treatment-naïve people with no evidence of decompensated cirrhosis.

 

CONTRACEPTION

PK OF STANDARD VS DOUBLE DOSE LEVONORGESTREL EMERGENCY CONTRACEPTION WITH EFAVIRENZ (ACTG 5375; Oral Session: Monday, March 8, 11:15am – 1:15pm EST) Kimberly Scarsi, et al.

Co-administrating levonorgestrel (LNG) emergency contraception with efavirenz (EFV) has been shown to significantly reduce concentration of LNG in healthy volunteers. While some guidelines recommend adjusting the dosage of LNG when combined with EFV, this strategy had yet not been assessed in pharmacokinetic or clinical studies. ACTG hypothesized that doubling the dose of LNG to 3mg would increase its exposure in people receiving EFV-based ART.

 

COMORBIDITIES

RISK FACTORS FOR PROGRESSION FROM PREDIABETES TO DIABETES IN PERSONS WITH HIV (ACTG 5322 (HAILO)/DACS 352; Science Spotlight) Mary Clare Masters, et al.

People living with HIV experience increased incidence and prevalence of diabetes mellitus compared to the general population. ACTG 5322 sought to identify risk factors (which have not been previously characterized) that would cause people living with HIV on ART with pre-diabetes to advance to diabetes mellitus.

 

FACTORS ASSOCIATED WITH SYSTEMIC IMMUNE ACTIVATION IN A GLOBAL HIV COHORT (ACTG 5332 (REPRIEVE); Science Spotlight) Sara Looby, et al.

Among people living with HIV who are taking ART, persistent systemic immune activation may contribute to atherogenesis, CVD events, and mortality. REPRIEVE is the first study to characterize factors associated with key indices of systemic immune activation among a global cohort of people living with HIV. The presenters report baseline data associated with markers of systemic immune activation.

 

DieT Quality by global burden of disease region in adults with HIV IN the REPRIEVE Trial (ACTG 5332 (REPRIEVE); Science Spotlight) Kathleen Fitch, et al.

Optimizing modifiable factors, such as diet, may delay onset or improve aging-associated comorbidities, including CVD. REPRIEVE evaluated diet quality across a global cohort of people living with HIV with low-to-moderate CVD risk who were receiving ART.

 

CORONARY ARTERY DISEASE (CAD), TRADITIONAL RISK AND INFLAMMATION

AMONG PWH IN REPRIEVE (ACTG 5332 (REPRIEVE); Science Spotlight) Steven Grinspoon, et al.

REPRIEVE is a large ongoing primary prevention trial of people living with HIV, who are at increased risk for cardiovascular disease (CVD). The REPRIEVE Mechanistic Substudy aimed to identify unique factors contributing to CVD in people living with HIV. The presenters report baseline data from REPRIEVE correlating CT angiography findings with biomarkers and other data.

 

ELEVATED PLASMA GALECTIN-9 IS ASSOCIATED WITH NON-AIDS EVENTS DURING SUPPRESSIVE ART (NWCS 411; Science Spotlight) Thomas Premeaux, et al.

Increased risk of morbidity and mortality among people living with HIV is partly driven by chronic inflammation. Soluble galectin-9 (Gal-9), a pleiotropic glycan-binding immunomodulatory protein, is an immune modulator with a variety of functions, including acting as an immune checkpoint molecule. It has been shown to be elevated in people living with HIV taking ART and associated with markers of HIV persistence, neurological complications, and indices of morbidity and mortality in HIV infection. NWCS 411 aimed to identify the relationship between Gal-9 and the occurrence of non-AIDS events in people living with HIV who are taking suppressive ART.

 

SOLUBLE IMMUNE CO-STIMULATORY MOLECULES ARE PREDICTIVE OF NON-AIDS EVENTS DURING SUPPRESSIVE ART (NWCS 411; Science Spotlight) Thomas Premeaux, et al.

Immune co-stimulatory molecules (molecules that amplify or counteract the initial activating signals provided to T cells from the T cell receptor), which exist in soluble forms in normal physiological conditions and are elevated in cancer and inflammatory diseases, may be promising early predictive biomarkers of adverse outcomes in people living with HIV. NWCS 411 aimed to identify the relationships between plasma levels of soluble immune co-stimulatory molecules and the incidence of non-AIDS events using a nested case-control study from the ACTG ALLRT cohort.

 

IMPACT OF REPRODUCTIVE AGING ON HIV PERSISTENCE IN CIS-GENDER MEN AND WOMEN WITH HIV (NWCS 443; Science Spotlight) Sara Gianella Weibel, et al.

Women represent the majority of HIV infections worldwide, yet sex differences in HIV reservoir dynamics during reproductive aging remain an under-explored area of research. NWCS sought to elucidate the intersection between aging and declining sex hormones among women and to determine the role of sex on the HIV reservoir dynamic.

 

IMPACT OF REPRODUCTIVE AGING ON IMMUNE FUNCTION IN CIS-GENDER MEN AND WOMEN WITH HIV (NWCS 443; Science Spotlight) Stephen Rawlings, et al.

NWCS 443 sought to gain better understanding of the changes in women’s immune system during reproductive aging as a crucial factor to inform treatment and cure strategies.

 

HIV TREATMENT ADHERENCE

MASS SPECTROMETRY IMAGING OF HAIR TO IDENTIFY DAILY MARAVIROC ADHERENCE IN HPTN 069/ACTG 5305 (ACTG 5305; Science Spotlight) Eli Rosen, et al.

Adherence monitoring in hair provides a long-term measure of behavior, but accurately classifying adherence by drug concentration may be less accurate for melanin-bound compounds like maraviroc because darker hair colors can absorb greater amounts of the drug. ACTG 5305 used mass spectrometry imaging to assess daily adherence to maraviroc-based PrEP regimens in HPTN 069.

 

CANNABIS USE ASSOCIATED WITH DECREASED ART ADHERENCE IN AGING PEOPLE WITH HIV (DACS 354; Science Spotlight) Jennifer Manuzak, et al.

Because cannabis use is common among people living with HIV, DACS 354 sought to longitudinally characterize the association between its use and ART adherence among older people living with HIV. The study found that among aging people living with HIV, cannabis use was associated with decreased ART adherence.

 

HIV DRUG RESISTANCE

DRUG RESISTANCE MUTATIONS IN HIV PROVIRUS ARE ASSOCIATED WITH HYPERMUTATIONS (NWCS 371; Science Spotlight) Yijia Li, et al.

While HIV drug resistance mutations tests are crucial to clinical care, current methods require the plasma RNA copy number to be ­­>500-1000 copies/ml and can only detect major viral quasispecies in peripheral blood. NWCS 371 evaluated the clinical relevance of HIV proviral sequencing, which overcomes the limit of plasma viral load requirement by detecting all the "archive mutations."

 

MUTATIONS IN GP41 IN PRIMARY HIV-1 ISOLATES CONFER RESISTANCE TO ANTIRETROVIRALS (ACTG 5273; Science Spotlight) Yuta Hikichi, et al.

Recent research demonstrated that the lab-adapted HIV-1 NL4-3 strain can develop resistance to dolutegravir. ACTG 5273 examined whether Env-mediated drug resistance arises in clinically relevant isolates, whether Env mutations can confer resistance to other classes of ARVs, and the possibility that Env mutations contribute to drug resistance in vivo.

 

About the ACTG

The AIDS Clinical Trials Group (ACTG), which is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and collaborating NIH institutes, was founded in 1987 as the world’s first HIV research network. 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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