Organizational Structure
STRUCTURE
The organizational structure of the ACTG reflects its broad scientific, therapeutic, and pathogenesis-based research agenda. The Executive Committee provides oversight and resource allocation through its Scientific Agenda Steering Committee. The four Scientific Committees, with input from and integration with the Other Committees and Resource Committees, are empowered to develop, implement, and monitor the scientific agenda of the ACTG.
LEADERSHIP
The leadership of the ACTG, drawn from recognized and respected HIV/AIDS researchers, develops, implements, and supervises the ACTG scientific agenda.
Executive Committee
Chair: Constance Benson, University of California, San Diego
Vice-Chair:
Daniel Kuritzkes, Harvard University, Massachusetts
The Executive Committee of the Adult ACTG is equivalent to the Board of Directors of a large organization. It is responsible and accountable for the proper conduct of ACTG studies for the ethical and professional standards of the ACTG, and for ensuring that the results of clinical trials and scientific endeavors are arrived at in the most time and cost effective manner possible. The Executive Committee is responsible for the approval of the scientific agenda of the ACTG, inclusive of both the domestic and international components; fiscal management of the ACTG including, but not limited to, establishment of the schedule for the Group Chair's reports to the Executive Committee; allocation of resources of the central ACTG Core Award including, but not limited to, establishment of the level at which approval by the Executive Committee is required for expenditure of funds; establishment of policies and procedures of the ACTG; establishment of performance standards and evaluation oversight for all participating sites, Support Laboratories, and members; determination and recommendation to the NIAID regarding site funding; determination of disciplinary action for participating sites and members; development of a problem-resolution and grievance policy and procedure; and development and monitoring of a group-wide conflict of interest policy and procedure for management of conflicts of interest.
In addition to the Chair and Vice-Chair, other members of the Executive Committee are representatives of the four Scientific Committees, the Pharmacology Committee, the Network Community Advisory Board (NCAB), Site Management and Clinical Care Committees, domestic and international Principal Investigators, the Operations Center, the Statistical and Data Analysis Center and the DAIDS.
The Executive Committee has subcommittees, which are responsible for the management of the ACTG.
The Scientific Agenda Steering Committee (SASC) oversees and coordinates the ACTG's research priorities, scientific agenda through the Research Agenda Committees, and patient and laboratory resources. This committee is chaired by the vice chair of the Executive Committee.
The Data Management Subcommittee sets guidelines for data collection methods in the ACTG to promote consistency.
The Site Evaluation Subcommittee (SES) develops performance measures and standards for the AACTUs and monitors performance of the AACTUs on an annual basis. The SES commends sites with outstanding performance and recommends remedial interventions for sites not meeting performance standards.
The Laboratory Evaluation Subcommittee (LES) was formed in 2004 to define objective performance measures for evaluating Support Laboratories and determining performance-based algorithms that will facilitate evaluation and funding decisions.
SCIENTIFIC COMMITTEES
Four Scientific Committees develop, implement, and monitor the scientific agenda of the ACTG.
Optimization of Antiretroviral Therapy (OpART) Committee
Chair: Roy M. Gulick, Cornell University
Vice-Chair: Richard H. Haubrich, University of California, San Diego
The Optimization of Antiretroviral Therapy (OpART) Committee aims to develop new treatment strategies to limit the replication of HIV-1, further understand HIV-1 resistance to antiretroviral therapy, and optimize use of resistance assays, develop and validate laboratory techniques, and improve and optimize study design. The Optimization of Antiretroviral Therapy (OpART) Committee has a Steering Committee.
Dr. Roy M. Gulick is Associate Professor of Medicine at Weill Medical College of Cornell University in New York City. He currently serves as Principal Investigator of the Cornell Clinical Trials Unit of the AIDS Clinical Trials Group (ACTG). He also is Co-Chairman of the Forum for Collaborative HIV Research, Board Member of the International AIDS Society-USA, and a member of the Panel on Clinical Practices for Treatment of HIV Infection of the U.S. Department of Health and Human Services. He previously served as Chairman of the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA). Dr. Gulick’s research interests include designing, conducting and analyzing clinical trials to refine antiretroviral therapy strategies and assess antiretroviral drugs with new mechanisms of action.
Optimization of Antiretroviral Therapy (OpART) Committee Members information (password required)
Optimization of Co-Infection and Co-Morbidity Management (OpMan) Committee
Chair: Susan Swindells, M.B.B.S., University of Nebraska
Vice-Chair: Thomas B. Campbell, M.D., University of Colorado Health Sciences Center
The Optimization of Co-Infection and Co-Morbidity Management (OpMAN) Committee focuses on opportunistic infections associated with HIV disease, neurological complications, AIDS-related malignancies and oral complications. The OpMAN also has an Oral HIV/AIDS Research Alliance (OHARA) and Neurology Subcommittees.
Dr. Susan Swindells is Medical Director of the HIV Clinic at the University of Nebraska Medical Center and is the Terry K. Watanabe Professor of Internal Medicine in the Section of Infectious Diseases. She is also Director of the UNMC Ryan White Title III Program, the Nebraska AIDS Drug Assistance Program, and the Nebraska AIDS Education and Training Center. A native of England, Dr. Swindells earned her medical degree from University College in London and did postgraduate training in England and at the University of Washington in Seattle. Dr. Swindells' main research interests are in opportunistic infections.
Optimization of Co-Infection and Co-Morbidity Management (OpMan) Committee Members information (password required)
Oral HIV/AIDS Research Alliance (OHARA) Subcommittee
Chair: Caroline Shiboski, D.D.S., M.P.H., Ph.D.
Vice-Chair: Jennifer Webster-Cyriaque, D.D.S., Ph.D.
The Oral HIV/AIDS Research Alliance (OHARA) Subcommittee is comprised of three centers, Case Western Reserve University, University of California San Francisco, and University of North Carolina, who have collaborated under the auspice of the OpMAN Scientific Committee to provide the capacity to investigate the oral complications associated with HIV/AIDS.
For more information, please contact the OHARA subcommittee via actg.oharastr@fstrf.org.
Oral HIV/AIDS Research Alliance (OHARA) Subcommittee Members information (password required)
Neurology Subcommittee
Neurology Subcommittee Members information (password required)
Translational Research and Drug Development (TRADD) Committee
Chair: Cara Wilson, University of Colorado Health Sciences Center
Vice-Chair: Charles Flexner, Johns Hopkins University
The Translational Research and Drug Development (TRADD) Committee focuses on the design of clinical trials for reconstituting HIV specific immunity and general immunomodulation.
Cara Wilson, MD, is Associate Professor of Medicine in the Divisions of Infectious Diseases and Clinical Immunology at the University of Colorado Health Sciences Center in Denver. She is also jointly appointed in the Department of Immunology at National Jewish Medical Research Center. Her basic research focuses on the role of the cellular immune response in control of HIV-1 replication and in the pathogenesis of HIV-1 infection. Her clinical research interests include the development of therapeutic vaccines and other immune-based therapies for HIV-1 infection.
Translational Research and Drug Development (TRADD) Committee Members information (password required)
Hepatitis Committee
Chair: Dr. Margaret Koziel, Beth Israel Deaconess Medical Center, Boston
Vice-Chair: Dr. Kenneth Sherman, University of Cincinnati, College of Medicine
The goal of the Hepatitis Committee is to define the natural history and epidemiology of viral hepatitis and fatty liver diseases in HIV infection, to develop strategies for the treatment of HCV and HBV coinfection, and to determine the factors involved in drug interactions, hepatotoxicity, and steatosis in coinfection.
Dr. Margaret Koziel is a staff physician at the Beth Israel Deaconess Medical Center and Associate Professor of Medicine, Harvard Medical School, Boston MA. She received her M.D. degree from Dartmouth Medical School and internal medicine training at the New England Deaconess Hospital, Harvard Medical School. Following clinical and research training in Infectious Disease at the Massachusetts General Hospital and Harvard Medical School, she joined the faculty of Beth Israel Deaconess Medical Center. She has a long interest in cellular immune responses against hepatitis C, recently focusing on the role of cellular immune responses in liver injury and mechanisms of viral persistence.
Hepatitis Committee Members information (password required)
OTHER Committees
Women's Health Inter-Network Scientific Committee
Co-Chair: Arlene D. Bardeguez, Newark, NJ
Co-Chair: Beatriz Grinsztejn, Porto Alegre, Brazil
The Women's Health Inter-Network Scientific Committee develops optimal strategies for the prevention and treatment of HIV disease and related complications among women.
Women's Health Inter-Network Scientific Committee (password required)
RESOURCE COMMITTEES
Site Management & Clinical Care
Chair: Diane Daria, University of Cincinnati
Vice Chair: Tammy Powell, University of Cincinnati
- ways to optimize the recruitment and retention of study subjects
- means to educate study volunteers and clinical staff
- strategies that consider the psychosocial needs of study subjects to enhance protocol adherence.
The committee is composed of site staff, including both domestic and international study coordinators, research nurses, data management personnel, pharmacists and representatives of allied organizations including DAIDS, FSTRF and community representatives.
There are four subcommittees: Protocol Development and Implementation, Outreach, Recruitment and Retention, Training and Education, and Pharmacy.
Site Management & Clinical Care Committee Member information (password required)
Laboratory Technologists
Chair: Cheryl Jennings, Rush-Presbyterian St. Luke's
Vice-Chair: David Shugarts, University of Colorado
The Laboratory Technologists Committee provides input for the standardization of laboratory related logistical processes and is composed of laboratory technologists from specimen processing laboratories and Support Laboratories.
Laboratory Technologist Committee Members information (password required)
Network Community Advisory Board (NCAB)
Co-Chair: Philip Anthony
Co-Chair: Lynn Kidd-Freeman
The Network Community Advisory Board (NCAB) is an all-volunteer group representing HIV-infected and affected communities and ACTG study participants. The NCAB provides a forum for meaningful and broad community input into the scientific efforts, operations, and activities of the AIDS Clinical Trials Group. The NCAB has a Steering Committee and New Members, Scientific Agenda, and Community Advisory Board Subcommittees.
SPECIALTY LABORATORIES
The ACTG provides access to laboratories with state-of-the-art expertise in specialized assay development and application. The ACTG funds these core laboratories and through them centralizes the virology, immunology, and pharmacology research specimen analysis.
The core laboratory approach affords uniformity of data, efficiency with reduced cost, streamlined specimen tracking, quality assurance, and rapid incorporation of novel techniques. In addition to routine laboratory testing the Specialty Laboratories (SL) are involved with the development of innovative assays and methodologies.
The following Speciality Laboratories were selected through a competitive renewal funding:
| Virology Specialty Laboratories | |
|---|---|
The Virology Laboratory infrastructure consists of virology specialty laboratories (VSLs). The VSLs carry out protocol-required virologic assays, undertake projects to investigate HIV pathogenesis questions prioritized by the HIV RAC/Virology SL scientific agenda, and develop/standardize new virologic assays for future application to ACTG clinical trials. One of the VSLs will conduct hepatitis studies. | |
| Harvard University | Daniel R. Kuritzkes |
| Stanford University | David Katzenstein |
| University of Alabama at Birmingham | Victoria Johnson |
| University of Pittsburgh | John Mellors |
| University of Washington | Robert W. Coombs |
| Immunology Specialty Laboratories | |
|---|---|
The Immunology Laboratory infrastructure consists of immunology specialty laboratories (ISLs). The ISLs carry out protocol-required immunologic assays and assays such as cytokine (IL-2, TNF) quantitation, lymphocyte proliferation, HIV-1 specific CTL and NK assays. One of the ISLs will study hepatitis immunology. | |
| Harvard University (Hepatitis) | Margaret Koziel |
| Case Western Reserve University School of Medicine | Michael Lederman |
| Rush-Presbyterian-St. Luke's Medical Center | Alan Landay |
| University of California - Davis | Richard B. Pollard |
| University of Pittsburgh | Charles Rinaldo Jr. |
| Pharmacology Specialty Laboratories | |
|---|---|
The Pharmacology Laboratory infrastructure consists of pharmacology specialty laboratories (PSLs). The PSLs carry out protocol-required pharmacologic assays as well as bioavailability, drug-drug interaction, and gender specific analyses. | |
| SUNY at Buffalo | Gene Morse |
| University of Alabama, Birmingham | Edward P. Acosta |
| University of California, San Francisco | Francesca Aweeka |
| University of Colorado Health Sciences Center | Courtney V. Fletcher |
| Human DNA Repository | |
| Vanderbilt University | David Haas |
OPERATIONS CENTER
The Operations Center coordinates, administers, tracks, documents, and supports all research activities of the ACTG. Major functions include the following:
- Coordinating protocol development
- Assembling protocol teams comprised of investigators, clinical staff, statistical and data management staff, laboratory specialists, and pharmaceutical representatives
- Providing experienced Clinical Trials Specialists to guide protocol teams in developing complete protocol documents
- Assuring rapid protocol development from Concept Proposal through IND submission
- Maintaining continual communication and discussion via conference calls and electronic mail among protocol team members
- Implementing recruitment/retention/compliance strategies developed by protocol teams
- Monitoring study-specific safety and toxicity issues
- Tracking publications related to study results
- Facilitating national meetings
- Providing administrative support
Yvette Delph, MD, is the Director of the Operations Center.
STATISTICAL AND DATA MANAGEMENT CENTER
Statistical Data Analysis
Senior level biostatisticians at the Statistical Data Analysis Center (SDAC) provide complete statistical support, from study design through data analysis and publication.
These biostatisticians:
- Are among the leading experts in clinical trial design and analysis and are associated with the Harvard School of Public Health
- Are core members of each protocol team, providing statistical input from study inception through publication
- Design, review, and revise the statistical section of protocols, as necessary
- Prepare and present interim analyses to an independent Data and Safety Monitoring Board
- Provide special toxicity reports, as required
- Conduct the final analysis described in the protocol, as well as secondary analyses suggested by the data
Michael Hughes, PhD., is the Director of the Statistical Data Analysis Center.
Data Management Center (DMC)
Data Management is provided by Frontier Science Technology and Research Foundation (FSTRF) of Amherst, N.Y. Experienced clinical data managers employ advanced system technologies to collect data from remote sites to a central mainframe computer. Each protocol team is assigned a clinical data manager who:
- Designs and develops the protocol-specific case report forms to optimize data collection (with input from the protocol team and selected clinical sites)
- Participates in protocol- and site-specific training
- Monitors the timeliness and quality of the data and contacts sites for corrections and delinquencies
- Provides advice and instruction to the clinicians in the accurate completion of study forms
- Runs standard reports at specified intervals for purposes such as preparation of annual FDA progress reports
- Acts as liaison between the team and the clinical sites concerning all aspects of data required during conduct of the study
Greg Pavlov is the Director of the Data Management Center.