• A Message From Leadership – Club Q Statement of Solidarity

    November 23, 2022 Alexis Sexton Spotlight

    Statement of Solidarity

    The ACTG mourns with those impacted by the senseless shootings that occurred at Club Q, an LGBTQIA+ club in Colorado Springs last weekend. This attack, which fell on the eve of Transgender Day of Remembrance, is horrifying — further shattering the sense of safety of LGBTQIA+ Americans across the country.

    Our network is proud to serve a diverse community of people, faculty, staff, and administrators. We are committed to fostering respect, inclusivity, and equity and to disrupting hate and bias whenever and wherever we encounter it. We must rise against hate in the strongest possible terms and stand together in solidarity and love with our LGBTQIA+ communities to demand an end to this epidemic of violence.

     

  • ACTG presents data showing success of hepatitis B vaccine among people living with HIV at IDWeek 2022

    October 20, 2022 Alexis Sexton Spotlight

    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, today presented a session demonstrating that a three-dose regimen of the HEPLISAV-B vaccine fully protected people living with HIV at IDWeek 2022, taking place in Washington D.C. from October 19-22, 2022.

    “Hepatitis B is a serious liver infection that frequently affects people living with HIV,” said ACTG Chair Judith Currier, M.D., M.Sc., of the University of California, Los Angeles. “This study shows for the first time that people living with HIV with no history of hepatitis B infection or vaccination were fully protected by this vaccine. Our findings about the protection levels associated with HEPLISAV-B among people living with HIV are likely to change clinical practice and have a profound impact on people living with HIV around the world.”

    The study, “High HBsAb seroprotection achieved 4 weeks after 3 doses of HepB-CpG vaccine in people living with HIV (PLWH) without prior HBV vaccination (ACTG A5379 Group B Preliminary Results)” takes place on Thursday, October 20, 2022, during the “Late-Breaking Vaccine Studies” session from 1:45-3:00 p.m. E.T., led by study chairs Kenneth Sherman M.D., University of Cincinnati College of Medicine, and Kristen Marks, M.D., Weill Cornell Medicine. ACTG 5379 is an ongoing, prospective, open-label study to evaluate the level of seroprotection provided by HEPLISAV-B for people living with HIV.

    This analysis included 68 people living with HIV who had not received a hepatitis B vaccine and showed no evidence of prior hepatitis B exposure. Participants were on antiretroviral therapy with CD4>100 cells/mm3 and HIV-1 RNA<1000 copies/mL. Participants received three doses of HEPLISAV-B (at weeks 0, 4, and 24) and achieved 100 percent seroprotection. No unexpected safety issues were observed.

    Participants enrolled at 13 global sites in the U.S., Thailand, and South Africa. Among them, 46 percent were male, 66 percent were Asian, 16 percent were Black, and 15 percent were white. The median age was 47.

    The Food and Drug Administration (FDA) approved the HEPLISAV-B vaccine in 2017 as a two-dose regimen for adults, but until now, there has been little data around its use among people living with HIV.

    Read more here.

     

  • ACTG makes three COVID-19-focused presentations at IDWeek 2022

    October 20, 2022 Alexis Sexton Spotlight

    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 two oral abstracts and one poster on COVID-19 studies at IDWeek 2022, taking place in Washington D.C. from October 19-22, 2022.

    “IDWeek is an important opportunity for the ACTG to present our latest findings on COVID-19,” said ACTG Chair Judith Currier, M.D., MSc, of the University of California, Los Angeles. “These presentations are all from the ACTG’s ACTIV-2 platform, which sought to rapidly identify COVID-19 treatments and better understand the pathogenesis of SARS-CoV-2. These findings expand our understanding about several key aspects of COVID-19, including the relationship between SARS-CoV-2 RNA levels in different compartments, predictors of nasopharyngeal viral clearance, and SARS-CoV-2 RNA levels as predictors for clinical outcomes.”

    ACTIV-2 is a randomized controlled adaptive platform that enabled the efficient testing of a variety of promising therapeutic agents for early COVID-19 within the same trial infrastructure. ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds the ACTG.

    ACTG COVID-19 presentations at IDWeek 2022 include:

    Nasal and plasma SARS-CoV-2 RNA levels predict timing of symptom resolution in the ACTIV-2 trial of non-hospitalized adults with COVID-19 (Friday, October 21, 11:00 a.m. E.T.); Oral session; Yijia Li, et al.

    This study sought to understand the relationship between SARS-CoV-2 burden in the upper airway or plasma and the duration of COVID-19 symptoms. Among individuals with COVID-19 who did not receive treatment, participants with high anterior nasal and detectable plasma RNA at study entry were more likely to experience symptoms for a longer period of time.

    Association between anterior nasal and plasma SARS-CoV-2 RNA levels and hospitalization or death for non-hospitalized adults with mild-to-moderate COVID-19 (Friday, October 21, 10:30 a.m. E.T.); Oral session; Mark J Giganti, et al.

    This study sought to expand upon the limited data available regarding the performance of SARS-CoV-2 RNA levels as predictors or surrogate markers for clinical outcomes in outpatients with mild-to-moderate COVID-19. Researchers found that anterior nasal and plasma SARS-CoV-2 RNA levels were predictive of hospitalization and death among participants who received placebo, but nasal viral levels explained only a small proportion of the beneficial treatment effect of monoclonal antibodies. Differing associations of nasal viral levels between monoclonal antibody and placebo recipients raise concerns about nasal RNA as a surrogate for clinical outcomes in monoclonal antibody trials.

    Female sex and SARS-CoV-2 serostatus predict nasopharyngeal RNA clearance during early COVID-19 (Friday October 21, 12:15 p.m. E.T.); Poster session; Carlee Moser, et al.

    This study sought to better characterize predictors of SARS-CoV-2 RNA levels and changes over time during early COVID-19. It found that shorter symptom duration, older age, white race, lower BMI and a lack of anti-SARS CoV-2 antibodies were associated with higher RNA in early COVID-19 infection. Female sex and the presence of antibodies were associated with faster viral clearance.

    To read more here.

  • ACTG Announces Results from Investigational Inhaled COVID-19 Treatment in ACTIV-2 Phase 2 Study

    October 4, 2022 Alexis Sexton Spotlight

    ACTG Announces Results from Investigational Inhaled COVID-19 Treatment in ACTIV-2 Phase 2 Study

    Los Angeles, Calif. – The AIDS Clinical Trials Group (ACTG), the largest global HIV research   network, which recently expanded its focus to include evaluating outpatient treatment for COVID-19, today announced results from a trial comparing SNG001, an inhaled formulation of interferon beta, with placebo in the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial (ACTG A5401). For more information about the trial, please visit the study website.

    ACTIV-2 is the first U.S. study to evaluate SNG001 (developed by Synairgen) among non-hospitalized people with COVID-19. SNG001 is self-administered as a nebulized dose (15.6 MIU) that participants inhale once daily for 14 days. Participants are trained to use the nebulizer device by study staff and take all doses at home.

    The SNG001 arm of the phase 2 ACTIV-2 platform trial enrolled 221 adults with mild-to-moderate COVID-19. Inhaled SNG001 was generally safe and well tolerated with fewer adverse events (AEs), including new Grade 3 or higher AEs, in participants who received SNG001 compared with those who received placebo.

    There were no statistically significant differences between the SNG001 and placebo arms in the proportion of individuals without detectable nasopharyngeal RNA at days 3, 7, and 14 post-treatment, or the duration of COVID-19 associated symptoms, the two primary measurements of efficacy in the study. However, as a secondary outcome, individuals who received SNG001 had a lower risk of hospitalization compared with individuals who received placebo (1/110 vs. 7/110, P=0.07). While the results were not statistically significant, the study was not designed to detect differences in hospitalization.

    “These results, including a decrease in hospitalizations and AEs among participants who received SNG001, are promising and warrant further investigation in a larger phase 3 clinical trial,” said William Fischer, M.D., University of North Carolina (UNC), a lead investigator of SNG001. “SNG001 is the first nebulized inhaled therapeutic to demonstrate promising results and, if confirmed in larger studies, could represent a potential treatment option for people who have COVID-19 but are not hospitalized.”

    ACTIV-2 is a randomized, blinded, controlled adaptive platform that allows promising therapies to be added and removed over the course of the study to efficiently test a variety of new agents within the same trial infrastructure. The SNG001 study is being led by Dr. Fischer and Upinder Singh, M.D., and Prasanna Jagannathan, M.D., both of Stanford University. ACTIV-2 is led by Kara W. Chew, M.D., M.S., University of California, Los Angeles (UCLA) and Davey Smith, M.D., University of California, San Diego (protocol chairs) and David Alain Wohl, M.D., UNC and Eric S. Daar, M.D., Lundquist Institute at Harbor-UCLA Medical Center (vice-chairs) and supported by ACTG Chair Judith Currier, M.D., M.Sc., UCLA and ACTG Co-Chair Joseph J. Eron, M.D., UNC.

    ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds the ACTG. ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments and vaccines. It also receives support from the Federal COVID Response-Therapeutics, the U.S. government’s multi-agency effort to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

    For more information about ACTIV-2, please visit www.riseabovecovid.org, www.actgnetwork.org, or clinicaltrials.gov.

    Read more here. 

  • IDSA Media Briefing on Monkeypox Treatment Trials

    October 3, 2022 Alexis Sexton Spotlight

    The leader of ACTG’s STOMP monkeypox treatment study Dr. Timothy Wilkin joined Dr. Carl Dieffenbach, Director of the NIH’s Division of AIDS and Dr. Demetre Daskalakis, White House National Monkeypox Response Deputy Coordinator, for an IDSA media briefing monkeypox treatment trials. Please check it out here!

  • STOMP: New ACTG monkeypox treatment trial

    September 21, 2022 Alexis Sexton Spotlight

    For more information about a new ACTG monkeypox study, click here.

  • ACTG announces launch of trial evaluating monkeypox treatment

    September 9, 2022 Alexis Sexton Spotlight

    STOMP Will Evaluate Tecovirimat in a Phase 3 Clinical Trial

    Los Angeles, Calif. – The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, which expanded its focus to conduct research into COVID-19, today announced the initiation of STOMP (Study of Tecovirimat for Human Monkeypox Virus), or A5418, a phase 3, randomized, placebo-controlled, double-blind trial evaluating the safety and efficacy of tecovirimat for the treatment of human monkeypox. The study has been designed to learn as much as possible in a broad population of people with monkeypox.

    “There is an urgent need for monkeypox treatments and this study will help us determine whether tecovirimat should be one of them,” said ACTG chair Judith Currier, M.D., M.Sc., University of California, Los Angeles. “The ACTG has designed this study to give us the greatest possible insights into whether and how tecovirimat works against monkeypox, including whether the virus develops resistance to the treatment. An important part of that design is the inclusion of children and pregnant people. The study will also evaluate markers that may tell us that the drug is working so we can identify future promising drugs. Beyond addressing the current outbreak, this study has the potential to profoundly inform the treatment of individuals who acquire monkeypox virus in endemic countries.”

    A global outbreak of monkeypox emerged in the spring of 2022 and has since spread throughout the world, with more than 56,000 cases in 103 countries and more than 21,000 cases in the United States. Monkeypox was first identified in 1958 and has caused an increasing number of infections annually in endemic countries. The current outbreak has been characterized by increased person-to-person transmission. Close contact during sexual activity is believed to play an important role in this outbreak. While most cases thus far have been reported among men who have sex with men, women and children have also been infected. There are currently no therapies approved to treat human monkeypox.

    Tecovirimat (SIGA Technologies, Inc.) is approved by the U.S. Food and Drug Administration (FDA) to treat smallpox, but it is not yet known if it can effectively or safely treat monkeypox.

    This multi-center trial will enroll more than 500 adults with monkeypox virus infection. Importantly, this trial will include people with severe disease and those at high risk of severe disease including pregnant and breastfeeding people, children, and individuals with underlying immune deficiency and active inflammatory skin conditions who will receive open-label tecovirimat. Study participants with symptomatic monkeypox virus infection who do not meet the criteria for the open-label cohort will be randomly assigned in a ratio of two to one to receive either tecovirimat or placebo orally for 14 days. Participants who are randomized in the double-blinded cohort of the study who later progress to severe disease will be offered the option to switch to open-label tecovirimat, as will participants who report persistent severe pain from monkeypox virus infection.

    All participants in STOMP will be followed for at least eight weeks through a combination of virtual and in-person visits and daily self-reports to determine if those receiving tecovirimat heal more quickly compared to those receiving placebo. STOMP will also provide critical data on the optimal dosing and safety of tecovirimat in children and people who are pregnant and breastfeeding.

    “Up until now, there have been no studies of tecovirimat in children or pregnant people, which means we lack any data on the risk and benefits of this treatment in two very important populations,” said STOMP protocol chair Timothy Wilkin, M.D., M.P.H., assistant dean of clinical research compliance and a professor of medicine at Weill Cornell Medicine. “In addition, while the data are limited, they do suggest that monkeypox can be more severe among children and pregnant people, so it will be key to understand how tecovirimat works for them.”

    Individuals who have presumptive or confirmed monkeypox infection (tested positive within seven days) and started experiencing symptoms within 13 days are eligible. Testing will be provided by the study. Participants with presumptive monkeypox virus infection who have not yet been tested are able to enroll as long as their study-provided test is positive. Participants must also have at least one active skin lesion that has not yet scabbed, a mouth lesion, or proctitis (inflammation in the lining of the rectum).

    STOMP is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds the ACTG.  A list of participating sites in the United States can be found here.

    STOMP is led by Dr. Wilkin and William Fischer, M.D., University of North Carolina (UNC) and Jason Zucker, M.D., Columbia University (vice-chairs) and is supported by Dr. Currier and Joseph J. Eron, M.D., UNC, (ACTG Co-Chair).

     

    Read more here.

  • A5418:Study of Tecovirimat for Human Monkeypox Virus (STOMP)

    September 9, 2022 Alexis Sexton Spotlight

    Now open and Enrolling. 

    Study Description

    The study of Tecovirimat for treatment of human Monkeypox (STOMP) is a NIAID-funded clinical trial led by the ACTG to evaluate the effectiveness of the antiviral tecovirimat, also known as TPOXX, for the treatment of human Monkeypox infection.

    Read more here.

     

  • Solicitation for ACTG Science Committee Membership Positions DUE September 21st

    August 26, 2022 Alexis Sexton Spotlight

    DEADLINE: Wednesday, September 21, 2022

    The AIDS Clinical Trials Group (ACTG) Network is currently soliciting for member nominations to the ACTG’s scientific committees. The ACTG is seeking qualified clinical and laboratory investigators with expertise relevant to the area of research who are willing to commit the time necessary to serve on the Transformative Science Groups (TSGs) and Collaborative Science Groups (CSGs). Interested investigators with appropriate expertise need not be affiliated with a funded ACTG Clinical Trials Unit (CTU) or Clinical Research Site (CRS) and/or have previous involvement with ACTG studies.

    • International investigators and junior investigators are strongly encouraged to submit their names in nomination to science committees appropriate to their interests.
    • International site personnel are strongly encouraged to submit their names in nomination to committees appropriate to their interests and experience.

    Current members of committees for whom a second term is permitted and who are interested in serving a second term must submit a nomination packet.

    VACANCIES:

    The detailed listing of position vacancies for the different committees is available on the ACTG Committee Nomination web site at https://nomination.mis.s-3.net/. The listing also specifies who is eligible for the positions, term duration, number of conference calls per month and meetings per year, and a brief description of duties and responsibilities of the positions.

    NOMINATION PROCESS:

    Nominations and required accompanying materials must be submitted online at https://nomination.mis.s-3.net/ by Wednesday, September 21.

    The individual position descriptions for the vacancies specify who may submit a nomination and when self-nominations are acceptable with the appropriate documentation.

    Nominees must submit all required documents and acknowledge their willingness to serve. The list of required documents, also available on the website, is as follows:

    1. Nomination letter outlining the candidate’s qualifications, relevant expertise, experience, and accomplishments pertinent to the position
    2. NIH biosketch (template available at http://grants.nih.gov/grants/forms/biosketch.htm and on the ACTG member web site)

    SELECTION PROCESS:
    Nominations for science committees will be distributed to the relevant committee for review and selection. The AEC will review and determine whether to endorse the selections made by the respective committees. Following the AEC review, the nominees will be notified of the election outcome. Once the committees have advised nominees of the outcome, the AEC will broadly announce the selections and post the results to the ACTG web site. 

    INQUIRIES

    Questions regarding the nomination process should be directed to the ACTG Network Coordinating Center at ACTGCommitteeNominations@dlhcorp.com.

  • Upcoming Monkeypox Study

    From NIAID

    In September 2022, NIAID will start a clinical trial of tecovirimat in the U.S. in collaboration with the AIDS Clinical Trials Group (ACTG). People with monkeypox infection, including people living with HIV, would be eligible and encouraged to enroll. More than 500 volunteer participants will be randomly assigned to receive either tecovirimat or a placebo at a ratio of two to one. Investigators will be evaluating if those taking tecovirimat heal more quickly than those taking placebo, among other data points. There is an additional segment of the study open to pregnant and breastfeeding people and children and all will receive tecovirimat and will be closely monitored for safety. If a positive signal is seen in the study, it will provide the necessary data to make this medicine readily available for treatment of monkeypox disease.