EXECUTIVE LEVEL COMMITTEES
The ACTG Executive Committee (AEC) is the primary governing body of the ACTG, with ultimate responsibility for all scientific, administrative, and fiscal decisions on behalf of the Network. Along with its key committees, the AEC oversees the overall fiscal management of the ACTG; develops network bylaws, policies, and procedures; establishes performance standards for network Centers and sites; ensures timely analysis and dissemination of study results; and works to enhance representation of underserved populations and participation by minority investigators in ACTG studies. The AEC is responsible for approving the leadership and membership of ACTG scientific and supporting committees.
Network Leadership Steering Committee
The ACTG Network Leadership Steering Committee oversees the administrative, scientific, and laboratory management of the ACTG and provides guidance to and coordinates the activities of the Leadership and Operations Center (LOC), the Network Coordinating Center (NCC), and the Statistical and Data Management Center (SDMC).
Scientific Agenda Steering Committee
The Scientific Agenda Steering Committee oversees all aspects of the development, refinement, and conduct of the ACTG’s scientific agenda and research plan, ensuring a clinical research agenda that addresses the National Institute of Allergy and Infectious Diseases (NIAID) scientific priorities and that responds to changes in the field.
The Data Management Committee works closely with the ACTG Data Management Center to develop and implement standardized electronic data collection methods and case report forms. The committee provides clinical, data management and analysis expertise to ensure collection of appropriate data from US and international sites to address data needs of ACTG clinical trials. The committee also aims to coordinate data collection methods of the ACTG with those of other NIAID/DAIDS networks to ensure consistent and standard data collection.
Performance Evaluation Committee
The Performance Evaluation Committee (PEC) monitors the performance of all key elements of the ACTG to ensure efficient development, implementation, and completion of clinical trials and the publication of study results. Through a continuous cycle of monthly reviews and interim and annual evaluations, the PEC assesses the structural components of the ACTG including the Leadership Operations Center (LOC); Network Coordinating Center (NCC); Statistical and Data Management Center (SDMC); specialty and site laboratories; and clinical research sites (CRSs).
The committee also identifies potential issues and obstacles to performance, provides real-time technical support and assistance, and makes recommendations to the ACTG Executive Committee for process improvements to facilitate the efficient execution of the Network’s scientific agenda. The PEC draws insight and expertise from a membership that encompasses the Network’s CRSs, laboratories, SDMC, NCC, and community representatives.
Underrepresented Populations Committee
The Underrepresented Populations Committee promotes and monitors the clinical trial participation of groups traditionally underrepresented in clinical research, and recommends strategies through which the ACTG Executive Committee can enhance the participation of underrepresented populations and minority investigators in HIV/AIDS research. The definition of underrepresented populations includes—but is not limited to—racial and ethnic minorities, women, transgender persons (and other sexual and gender minorities), individuals who use drugs, persons who face barriers to adherence, and individuals with disabilities. Membership in the committee is updated regularly and comprises elected members and representatives from other committees and stakeholders within the ACTG. The committee also oversees the selection of candidates for the ACTG Minority HIV Investigator Mentoring Program (MHIMP) and the ACTG International HIV Investigator Mentoring Program (IHIMP).
End-Organ Disease and Inflammation Transformative Science Group
People living with HIV, even when highly adherent to treatment, are at increased risk for several end organ diseases, including cardiovascular disease, diabetes, hypertension, chronic kidney disease, osteoporosis, neurocognitive impairment, and declines in physical function. HIV-associated alterations in immune function and persistent inflammation appear to contribute to the excess risk of these diseases.
The End-Organ Disease and Inflammation Transformative Science Group (TSG) fosters collaboration among virologists, immunologists, pharmacologists, and clinical and laboratory researchers to design clinical trials of novel interventions targeting end-organ diseases that contribute to increased morbidity and mortality among people with HIV. The TSG also conducts observational studies using existing ACTG data and samples to evaluate the causes and consequences of these end-organ diseases and the role of HIV infection; interventional studies of other host-targeted therapies designed to enhance immune recovery; and studies to understand the influence of other key factors, such as age, race, and sex, on the clinical consequences of HIV infection.
Antiretroviral Therapy Strategies Transformative Science Group
The Antiretroviral Therapy Strategies Transformative Science Group oversees ACTG studies evaluating the effectiveness of novel treatment strategies — including long-acting antiviral drugs and formulations, broadly neutralizing and other monoclonal antibodies, and novel combinations of biomedical and behavioral modalities — in sustaining virologic suppression and engagement in HIV care globally. The TSG also:
- Creates partnerships to evaluate promising treatment delivery technologies, interventions, and strategies
- Evaluates pharmacokinetic interactions between antiviral agents and other compounds
- Partners with other networks to strengthen or broaden the evaluation of novel treatment strategies with HIV prevention applications
- Assists as needed in the evaluation of novel therapeutic agents for emerging infectious diseases.
Hepatitis Transformative Science Group
The ACTG Hepatitis Transformative Science Group facilitates trials of novel therapeutics in liver disease of people living with HIV infection, including liver disease related to hepatitis B virus (HBV) and hepatitis C (HCV) infection and metabolic disorders. Specifically, the TSG:
- Interacts with companies with promising therapeutic compounds (e.g. antivirals, antifibrotics) to determine the best approach to developing an understanding of the efficacy and safety of the drug or combinations of drugs and to consider unique patient populations relevant to the ACTG mission. The TSG also considers the incorporation and validation of predictive and prognostic candidate biomarkers for each drug regimen.
- Encourages and facilitates collaboration between laboratory and clinical scientists, experts in virology, immunology, pharmacology, and genetics, and industry partners, in order to facilitate rapid protocol development and study enrollment.
- Educates ACTUs about candidate selection, drug-drug interactions, and end-stage liver disease.
- Works to ensure that ACTG studies of these novel agents represent the face of HIV in the U.S. and internationally by encouraging the participation of underrepresented individuals, including women and persons of color.
- Encourages the training of the next generation of hepatitis researchers with particular focus on international investigation.
HIV Reservoirs and Viral Eradication Transformative Science Group
Even after treating HIV with potent antiretroviral medications, the virus persists in some cells (“the HIV reservoir”), where it hides from the immune system. Our ultimate goal in the Cure TSG is to cure HIV either through the complete elimination of the HIV reservoir (“sterilizing cure”) or by controlling the virus in the absence of antiretroviral treatment (“functional cure”).
The Cure TSG scientific priorities are to:
- Fully characterize the HIV reservoirs in blood and tissues
- Identify and validate methods to quantify the HIV reservoir, which then can be used in clinical trials that target it
- Understand by what means people have been cured of HIV infection after bone marrow transplantation (The Berlin and the London patients), and try to replicate them if possible
- Better understand the mechanisms that maintain the HIV reservoir and how they relate to immune activation and immune exhaustion
- Identify the most promising new therapies to cure HIV and evaluate them in pilot “proof-of-concept” cure studies
The complexity of HIV persistence and curing HIV requires a broad approach that involves TSG members and guest scientists from many different disciplines, both within and outside the ACTG, and from academia and industry.
Tuberculosis Transformative Science Group
The Tuberculosis (TB) Transformative Science Group is responsible for development, implementation, and oversight of the ACTG research agenda related to the treatment and prevention of TB with and without HIV co-infection. The primary objectives of the TB TSG are to:
- Develop shorter, safer treatment regimens for drug-susceptible and resistant TB disease
- Identify optimal TB preventive therapy for drug-susceptible latent TB infection and household contacts exposed to multi-drug resistant TB
- Identify regimens for the treatment of TB meningitis and isoniazid-monoresistant TB (areas of high unmet medical need)
- Optimize TB treatment and prevention in TB/HIV co-infected people
Additional aims include conducting transformative research to:
- Describe drug-drug interactions involving anti-TB therapy and ART
- Improve TB diagnostic assays and biomarkers to predict and detect disease and to monitor response to therapy
- Develop novel TB clinical trial designs
Women represent large proportions, and in many regions of the world, a majority of people living with HIV infection. Yet, they are often underrepresented in HIV research. The Women’s Health Inter-Network Scientific Committee (WHISC) works to develop optimal strategies for the treatment of HIV disease and related complications among women. To this end, the WHISC develops studies that address scientific questions of high importance to the health of women living with HIV. It also seeks to optimize recruitment, retention, and sex-specific analyses of women in clinical trials. It advises the ACTG on clinical trial language and makes recommendations regarding reproductive, contraception, and pregnancy issues. It serves as a liaison with other networks, groups, and agencies involved in the care and treatment of women to enhance communication and avoid duplication in clinical trials. Finally, the committee seeks to mentor junior faculty with careers directed at research into the health of women living with HIV. The current WHISC scientific agenda seeks to:
- Assess optimal therapy of HIV/AIDS, TB, hepatitis, and ‘cure’ strategies in women living with HIV over the course of their lifetime
- Identify critical drug-drug interactions between hormonal therapies and antiviral drugs, TB drugs, hepatitis treatment, and cure interventions in women living with HIV
- Determine sex differences in comorbidities (e.g., cardiovascular disease, depression, obesity, aging) and responses to their treatments in people living with HIV
Neurology Collaborative Science Group
The areas of highest priority for investigation by the Neurology CSG include:
- HIV-associated cognitive impairment
- HIV eradication and the central nervous system as a reservoir of HIV infection
- Mental health and behavior of women and men living with HIV
- HIV-associated CNS opportunistic infections
- Neurologic toxicities of ARV and other drugs
- Distal sensory peripheral neuropathy
Membership in the Neurology CSG comprises academic neurologists, psychiatrists, pharmacologists, virologists, and infectious diseases specialists. The committee includes working groups addressing HIV and aging, virology, mental health, women’s issues, and HIV cure.
Global Community Advisory Board
The ACTG Global Community Advisory Board (GCAB) supports community outreach, education, and participation in research, and represents community concerns in the ACTG. Comprised of a member from the CAB at each ACTG Clinical Research Site (CRS), the GCAB works to integrate community involvement into site plans and operations to advance HIV/AIDS research. The GCAB provides an opportunity for affected communities, and especially for the participants in ACTG clinical trials, to:
- Better understand the clinical research process
- Voice questions or concerns regarding clinical studies, their development, implementation and outcomes
- Contribute their knowledge, perspective, and experience to efforts to enroll and retain trial participants
- Advocate on behalf of clinical trial participants
- Volunteer for protocol teams and subcommittees
- Mentor new members and ask for mentorship when needed
- Help keep research in the forefront of technology/communication systems
- Ensure that trial materials are available in all appropriate languages
- Promote ethical research practices
GCAB members are selected by their CABs and serve two-year terms. CGAB members may also be selected to serve on the non-scientific ACTG committees. Participation by the community on ACTG committees and protocol reviews is conducted through the Community Scientific Subcommittee (CSS) of the GCAB.
Site Management & Clinical Care
The Site Management & Clinical Care Committee (SMCCC) oversees logistical processes essential for successful implementation and completion of the ACTG scientific research agenda. The mission of the SMCCC is to provide practical advice and technical expertise in the areas of patient care, data collection and management, and site operations as they relate to the safe and successful execution of ACTG clinical trials. The SMCCC is composed of site coordinators, research nurses, regulatory and data management personnel, pharmacists, and representatives of allied organizations including the NIH Division of AIDS (DAIDS), the Frontier Science Technology and Research Foundation (FSTRF), and community representatives.
The SMCCC is comprised of two subcommittees and six working groups:
- Protocol Development and Implementation Subcommittee (PDISC)
- Field Representatives Working Group
- Outreach, Recruitment and Retention Working Group
- Pharmacy Working Group
- Site Operations Subcommittee (SOS)
- Data and Quality Management Working Group
- Study Coordinators Working Group
- Training and Education Working Group
Leadership and Operations Center
The ACTG Leadership and Operations Center (LOC) Administrative Core comprises Grants & Contracts, Budget & Finance, and Leadership Support teams and is housed within the Division of Infectious Diseases at University of California Los Angeles (UCLA). The Administrative Core is responsible for:
- Managing all funds awarded to the LOC and Laboratory Center (LC)
- Developing budgets; negotiating and executing contracts on behalf of the LOC and LC; and monitoring spending and financial activity on all LOC and LC awards
- Maintaining all LOC and LC administrative and fiduciary records
- Managing conference support for annual ACTG network meetings and leadership and scientific retreats
- Maintaining the financial conflict of interest (FCOI) disclosure program
- Tracking ACTG publications and ensuring compliance with NIH open access requirements
- Preparing annual progress reports and other administrative reports to the NIH Division of AIDS (DAIDS)
- Providing administrative and financial support to the ACTG Executive Committee (AEC)
- Coordinating ACTG external communications, social media, and press releases
The Administrative Core is led by the LOC Executive Director, Alexis R. Sexton and reports to the ACTG Network Leadership Steering Committee (LSC).
Network Coordinating Center
The ACTG Network Coordinating Center (NCC), housed at Social & Scientific Systems, Inc. (SSS), collaborates with ACTG leadership to provide technical, scientific, and administrative support for the network. The NCC facilitates implementation of the ACTG scientific research agenda, harmonizes network responsibilities, and ensures compliance with policy and procedures among ACTG leadership, sites, and partners. Among its responsibilities, the NCC provides:
- Administrative, management, technical, and clinical support for the network leadership, committees, and sites, and for community advocates and representatives
- Support for protocol development and implementation; laboratory structure development, quality assurance, and training; site capacity development, assessment, training and quality assurance; and publication of ACTG research
- Support for network communications, including quality assurance for information stored on the network’s Management Information System (MIS) and secure web-based document management system, integration with Network websites, and coordination with other DAIDS-funded networks
- Management of study protocol development including protocol documents, manuals, and safety monitoring
As an ACTG Network Consortium Partner, the NCC Director is a member of the ACTG Executive Committee (AEC).
Statistical and Data Management Center
The ACTG Data Management Center (DMC) at Frontier Science Foundation acts as liaison between the team and the clinical sites concerning all aspects of data required during a study. The DMC supports each ACTG protocol team by:
- Facilitating the design and development of electronic case report forms to optimize study data collection
- Participating in protocol- and site-specific training
- Monitoring the timeliness and quality of study data, and working with sites to address any issues or delinquencies
- Providing advice and instruction to sites in the accurate completion of study forms
- Preparing data for annual FDA progress reports and other reports as needed
Marlene A. Cooper, M.S. is the Director of the Data Management Center.
Performance Evaluation Program
The ACTG Performance Evaluation Program is a comprehensive monitoring and evaluation system, working to ensure that all sites and laboratories across this multicenter, multinational clinical trials group contribute to the successful development, implementation, execution, completion, and publication of ACTG trials. Information gleaned from the evaluation program informs the development of the network’s scientific agenda and provides reliable data for strategic planning.
The ACTG Performance Evaluation Committee (PEC) administers the program and develops the evaluation tools to measure performance of the clinical research sites, laboratories, and other key components of the network.
Drawing insight and expertise from a membership that encompasses the network’s research sites, specialty laboratories, statistical and data management center, network coordination center, and community representatives, the PEC develops performance measures and standards that focus on the efficient use of resources, scientific quality, data integrity, safety, and the protection of research participants.
Because performance evaluation is a continuous process, the PEC monitors performance data on a cycle of monthly data reviews, interim performance reviews, and formal annual performance evaluations. Continuous monitoring helps the PEC detect potential issues at an early stage and provide real-time technical support and recommendations to ensure clinical research sites and specialty laboratories meet the network’s goals and expectations for high quality performance.