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 six oral and 27 poster sessions at the Conference on Retroviruses and Opportunistic Infections (CROI 2022), which will be held virtually February 12-16, 2022. CROI is the premier global HIV research conference and ACTG’s significant presence at the meeting demonstrates its continued leadership in HIV and related fields.
“The ACTG has continued to lead high-impact HIV research, including work on tuberculosis, HIV cure, co-morbidities, hepatitis, and now COVID-19, for more than 30 years,” said ACTG Chair Judith Currier, M.D., MSc, of the University of California, Los Angeles. “Highlights of our presentations at CROI this year include findings on COVID-19 among people living with HIV, interactions between emergency contraception and TB treatment, and insights into neurocognitive and functional impairment among people living with HIV. Our presence at this year’s meeting demonstrates our commitment to advancing a broad array of research to support people living with and vulnerable to these conditions.”
ACTG presentations are listed below by topic.
COVID-19
COVID-19 VACCINATION RATES IN A GLOBAL HIV COHORT (ACTG 5332/REPRIEVE; Oral Presentation: Monday, February 14, 2022, 1:09 PM EST) Evelynne S. Fulda, et al.
This study investigated COVID-19 vaccination rates among participants in ACTG 5332/ REPRIEVE (Randomized Trial to Prevent Vascular Events), a global primary cardiovascular prevention trial among people living with HIV in 12 countries, in order to better understand rates among this immunocompromised population with significant morbidity from COVID-19.
CAMOSTAT IS NOT EFFECTIVE FOR MMILD-MODERATE COVID-19 IN A PHASE II TRIAL OF ACTIV-2 (ACTG 5401/ACTIV-2; Oral Presentation: Tuesday, February 15, 2022, 1:17 PM EST) Nick Jilg, Kara Chew et al.
This study evaluated the safety, antiviral, and clinical efficacy of orally administered camostat, a serine protease inhibitor, in non-hospitalized adults with mild-moderate COVID-19.
POST-ACUTE SEQUELAE OF SARS-COV-2 IN NON-HOSPITALIZED ACTIV-2 TRIAL PARTICIPANTS (ACTG 5401/ACTIV-2; Poster Presentation: Monday, February 14 2022, 4:00 PM – 5:30 PM EST) Teresa H. Evering, et al.
ACTG 5401/ACTIV-2 is an ongoing phase 2/3 study evaluating the safety and efficacy of investigational treatments to treat non-hospitalized adults with mild to moderate COVID-19. This analysis reports on symptom diaries completed by participants.
ASYMPTOMATIC SARS-COV-2 INFECTION IS EXTREMELY COMMON AMONG PEOPLE WITH HIV (ACTG 5332/REPRIEVE; Poster Presentation: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Isabelle R. Weir, et al.
While asymptomatic COVID-19 is common among the general population, it has not been examined specifically among people living with HIV. This study presents data on asymptomatic COVID-19 among people living with HIV in the REPRIEVE cohort.
PHASE-2 EVALUATION OF SAB-185, A POLYCLONAL ANTIBODY TREATMENT FOR COVID-19 in ACTIV-2 (ACTG 5401/ACTIV-2; Poster Session: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Babafemi Taiwo, Kara Chew, et al.
ACTIV-2 evaluated the safety and efficacy of the investigational polyclonal antibody treatment SAB-185 among non-hospitalized adults with mild-moderate COVID-19.
TUBERCULOSIS
PK OF DOSE-ADJUSTED EMERGENCY CONTRACEPTION WITH RIFAMPICIN THERAPY IN ACTG A5375 (ACTG 5375; Oral Session: Tuesday, February 15, 2022, 1:01 PM EST) Rosie Mngqibisa, et al.
Expanding access to contraception is essential to prevent pregnancy-related health risks for women with tuberculosis, but drug-drug interactions are a concern, as rifampicin reduces levonorgestrel (for emergency exposure) by 57%. This study evaluates whether an adjusted dose of levonorgestrel during rifampicin therapy would result in similar PK exposure compared to standard dose levonorgestrel in the absence of the drug-drug interaction.
DTG PK IN PEOPLE WITH HIV RECEIVING DAILY 1HP FOR LATENT TB TREATMENT (ACTG A5372; Oral Session: Tuesday, February 15, 2022, 1:09 PM EST) Marjorie Imperial, et al.
This study evaluated the effect of 1HP (a 28-day regimen of daily rifapentine+isoniazid) on the pharmacokinetics of dolutegravir to assess a potentially clinical relevant drug interaction.
HIV RESERVOIRS AND CURE STRATEGIES
POST-TREATMENT CONTROLLERS MAINTAIN A LIMITED INTACT RESERVOIR AFTER ART INTERRUPTION (ACTG 5068; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Yijia Li, et al.
HIV post-treatment controllers (PTCs) are people living with HIV who are able to maintain viral suppression after an analytical treatment interruption (ATI). A5068 evaluated HIV-1 proviral dynamics before and after ATI in PTCs and non-controllers (NCs).
ACTG A5351S: EFFECT OF IMMUNE-MODULATORY INTERVENTIONS ON CMV REPLICATION DURING ART (ACTG 5351s; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Elizabeth Hastie, et al.
This study investigated the impact of different immune modulating interventions on CMV replication.
N-GLYCOSYLATION SITES DIFFERENTIATIONS BETWEEN PTCS AND NCS (NWCS 380; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Elmira Esmaeilzadeh, et al.
Viral evolution is frequently modulated by host immune pressures and comparing viral sequence changes in PTCs and post-treatment NCs may provide insight on mechanisms behind HIV remission. This analysis of NWCS 380 sought to elucidate the link between the N-glycosylation sites in the HIV envelope (which play a critical role in viral evolution and immune escape against humoral immune responses) and post-treatment control.
POST-TREATMENT CONTROLLERS LIMIT COMPLETED AND SPLICED HIV TRANSCRIPTS AFTER ATI (NWCS 380; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Adam Wedrychowski, et al.
The mechanisms that allow PTCs to limit viral replication after ATI remain unclear. This analysis evaluated whether PTCs would show greater blocks to HIV transcriptional completion and splicing following ATI than NCs.
SIZE AND ACTIVITY OF THE HIV RESERVOIR PREDICT REBOUND TIMING AFTER ART INTERRUPTION (ACTG 5345; Poster Session: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Jonathan Z. Li, et al.
Identifying biomarker predictors of HIV rebound timing is crucial for accelerating the design and evaluation of effective interventions for HIV remission. ACTG 5345 assessed associations between reservoir measures and the timing of viral rebound.
T CELLS EXPRESSING MULTIPLE INHIBITORY RECEPTORS PERSIST ON LONG-TERM ART (ACTG 5321; Poster Session: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Bernard JC Macatangay, et al.
Expression of multiple IRs is associated with T cell exhaustion in chronic viral infections. ACTG 5321 compared frequencies of T cells expressing ≥2 IRs among people living with HIV and in age-matched individuals who were HIV-negative.
INHIBITORY RECEPTOR EXPRESSION CORRELATES WITH HIV PERSISTENCE AND IMMUNE RESPONSES (ACTG 5321; Poster Session: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Bernard JC Macatangay, et al.
T cell expression of inhibitory receptors (IR) has been associated with measures of HIV persistence and immune responses to HIV. ACTG 5321 evaluated which combinations of IRs were associated with HIV persistence and HIV-specific immune responses in a cohort of people living with HIV with suppressed plasma viremia.
EARLY ANTIRETROVIRAL THERAPY REDUCES BUT DOES NOT ELIMINATE HIV DNA IN BLOOD (ACTG 5354; Poster Session: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Trevor A. Crowell, et al.,
Antiretroviral therapy (ART) initiated during acute or early HIV infection may limit HIV reservoir formation and facilitate HIV remission. ACTG 5354 evaluated HIV DNA levels in blood at and after suppressive ART initiation across acute and early stages of HIV infection and found that ART initiation in earlier stages reduced but did not eliminate the persistence of HIV-infected cells in blood.
HIV-SPECIFIC T CELL FREQUENCIES AND FUNCTION AFTER ART DURING ACUTE OR EARLY HIV (ACTG 5354; Poster Session: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Scott Sieg, et al.
The immunologic effects of starting ART during acute or early HIV infection are not well defined. This study evaluated the impact of early ART on antigen exposure and T cell immune responses.
FEASIBILITY AND VIRAL RESPONSE TO TREATING ACUTE/EARLY HIV IN A MULTINATIONAL STUDY (ACTG 5354; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) Eric S. Daar, et al.
This study reports on the feasibility of rapidly identifying individuals with suspected acute or early HIV infection, starting ART, and achieving viral suppression during acute or early HIV infection.
HIV ENVELOPE DIVERSITY AND SENSITIVITY TO BNABS ACROSS STAGES OF ACUTE AND EARLY HIV (ACTG 5354; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) Laurie VanderVeen, et al.
Genetic diversity of the HIV envelope complicates use of broadly neutralizing antibodies (bNAbs) for HIV treatment and cure. ART during acute or early HIV infection restricts reservoir size and diversity, increasing the likelihood of bNAb susceptibility. Because successful treatment of ART-suppressed patients with bNAbs requires understanding the evolution of HIV envelope diversity, this study characterized both HIV envelope diversity and bNAb sensitivity at initiation of ART during acute or early HIV infection and after ART suppression.
IMMUNE RESPONSES FOLLOWING ANTI-PD-1 MONOCLONAL ANTIBODY INFUSION IN PERSONS WITH HIV (ACTG 5370; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) Bernard JC Macatangay, et al.
PD-1 expression on T cells is associated with cellular exhaustion in HIV. ACTG 5370 evaluated multiple immunologic parameters following infusion of an anti-PD1 monoclonal antibody in ART-suppressed people living with HIV.
HEPATITIS C
ADHERENCE IN THE ACTG 5360 HCV MINIMAL MONITORING (MINMON) TRIAL (ACTG 5360/MINMON; Poster Presentation: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Leonard Sowah, et al.
Understanding of the association between adherence and treatment outcomes and correlates of non-adherence among people receiving direct-acting antivirals for hepatitis C is limited. This analysis of ACTG 5360 (MINMON), a multinational trial to evaluate the safety and efficacy of 12 weeks of sofosbuvir/velpatasvir with reduced in-person visits and laboratory monitoring, evaluated the association of adherence with sustained virologic response and correlates of adherence.
COMORBIDITIES and AGING
GEOGRAPHICAL DIFFERENCES IN FUNCTIONAL IMPAIRMENT OF PEOPLE WITH HIV (ACTG 5332; Oral Session: Monday, February 14, 2022, 11:50 AM EST) Kristine M. Erlandson, et al.
Functional impairments occur at a younger age among people living with HIV. ACTG 5332 sought to better understand multinational differences (by Global Burden of Disease regions) in functional status and associated factors in the REPRIEVE cohort.
L-FERRITIN AND TIM-1 ARE ASSOCIATED WITH FRAILTY MEASURES IN PEOPLE WITH HIV (ACTG 5322/HAILO; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Harpreet Kaur, et al.
ACTG 5322 evaluated whether lower serum levels of the antioxidant iron transporter heavy-chain (H)-ferritin (Fth1) and light-chain (L)-ferritin (Ftl), and higher levels of urine T-cell immunoglobulin and mucin domain (Tim)-1 (Fth1 receptor) were associated with worse frailty among people living with HIV, who are generally at high risk of physical-function impairment and frailty.
H/L-FERRITINS AND TIM-1 ASSOCIATE WITH NEUROCOGNITIVE FUNCTION IN PEOPLE WITH HIV (ACTG 5322/HAILO; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Harpreet Kaur, et al.
ACTG 5322 investigated the association between Fth1, Ftl, and Tim-1 levels and neurocognitive impairment in people living with HIV.
ASSOCIATIONS BETWEEN PLASMA BIOMARKERS AND NEUROCOGNITION IN ART-TREATED PWH (NWCS 447; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Robert Kalayjian, et al.
NWCS 447 examined associations between plasma biomarker concentrations of inflammation and gut integrity with prevalent/incident neurocognitive impairment and cognitive trajectories in aging participants living with HIV receiving ART in the HAILO study.
NAFLD IS COMMON AMONG REPRIEVE PARTICIPANTS AND ASSOCIATED WITH CARDIOVASCULAR RISK (ACTG 5332/REPRIEVE; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Carl J. Fichtenbaum, et al.
Non-alcoholic fatty liver disease (NAFLD) is common among people living with HIV and is associated with elevated cardiovascular disease risk. This study presents baseline data on the prevalence and cardiometabolic characteristics of NAFLD among REPRIEVE participants who underwent computed tomography.
IMMUNE ACTIVATION AND SUBCLINICAL ATHEROSCLEROSIS AMONG US FEMALES VS. MALES WITH HIV (ACTG 5332/REPRIEVE; Poster Session: Monday, February 14, 2022, 4:00 PM – 5:30 PM EST) Markella V. Zanni, Borek Foldyna, et al.
This analysis characterized sex differences (which may be influenced by underlying differences in immune indices, coronary plaque parameters, or relationships therein) in presentations of atherosclerotic cardiovascular disease among REPRIEVE participants.
PROTEINURIA IS COMMON AMONG PEOPLE WITH HIV WITH CONTROLLED HIV VIREMIA (ACTG 5332/REPRIEVE; Poster Session: Tuesday, February 15, 2022, 4:00 PM – 5:30 PM EST) Edgar T. Overton, et al.
This study evaluated the prevalence of proteinuria and albuminuria, important markers of chronic kidney disease, among REPRIEVE participants on ART.
ACTG A5324: A randomized trial of ART intensification for cognitive impairment in PWH (ACTG 5324; Oral Session: Wednesday, February 16, 2022, 1:09 PM EST) Scott Letendre, et al.
Cognitive impairment in people living with HIV on suppressive ART may result from persistence of HIV in the central nervous system. A5324 evaluated whether ART intensification would improve neuropsychological performance among people living with HIV who had neurocognitive impairment on suppressive ART.
IMPACT OF INTEGRASE STRAND TRANSFER INHIBITORS ON COGNITION IN THE HAILO COHORT (ACTG 5322/HAILO; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) Jane A. O’Halloran, et al.
ACTG A5322 (HAILO, HIV Infection, Aging and Immune Function Long-term Observational Study) evaluated people aging with HIV who had switched to an integrase strand transfer inhibitor (INSTI) in an effort to better understand the impact of ART on neuropsychological outcomes, particularly cognition.
HIV TREATMENT STRATEGIES
Efficacy OF Tenofovir-Lamivudine-Dolutegravir FOR INITIAL AND FIRST-LINE SWitch ART (ACTG 5381; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) Cissy Kityo, et al.
The single-tablet tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) has been rapidly adopted as first-line ART for adults and adolescents initiating treatment and switching from virally suppressive NNRTI-based first regimens in PEPFAR programs despite limited data on effectiveness and emergence of resistance to TLD in these settings where plasma HIV-1 RNA and drug resistance testing are not widely used. ACTG 5381 assessed therapeutic efficacy and emergence of HIV drug resistance following TLD initiation for first-, second-, or third-line ART.
PHARMACOGENETICS OF WEIGHT GAIN AFTER SWITCH TO INTEGRASE INHIBITOR-BASED REGIMENS (DACS 349; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) David Haas, et al.
Excessive weight gain affects some people living with HIV after they switch to INSTI-based ART. DACS 349 studied associations between CYP2B6 genotype and weight gain after switching from efavirenz- to INSTI-based ART among participants in ACTG observational cohort studies A5001 and A5322.
EX VIVO ASSAY PREDICTS HIV-1 SUPPRESSION BY BNABS INFUSED IN A PHASE I CLINICAL TRIAL (ACTG 5378; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) Sabrina Helmold Hait, et al.
This study evaluated whether a newly developed ex vivo assay was able to predict the potential for a bNAb to induce an in vivo virologic response among people living with HIV who were viremic.
HIV PREVENTION
EXPECTATIONS OF PREVENTIVE BENEFITS AND HIV-RELATED RISK BEHAVIORS IN HPTN069/ACTG 5305 (ACTG 5305/HPTN069; Poster Session: Wednesday, February 16, 2022, 4:00 PM – 5:30 PM EST) Jeremy Sugarman, et al.
HPTN069/ACTG A5305 evaluated whether participants’ preventive misconceptions (expectations that experimental interventions will confer protection from HIV) increased the likelihood that they would engage in behaviors that could increase their chance of acquiring HIV.
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. More recently, The ACTG has expanded its focus to include the evaluation of outpatient treatments for COVID-19. 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.