The National Institute of Allergy and Infectious Diseases (NIAID) today announced it will make 32 four-year awards for the Adult AIDS Clinical Trials Group (ACTG), a nationwide, multicenter clinical trials network that tests new drugs and treatment strategies for adults infected with the human immunodeficiency virus (HIV).
The Adult ACTG will include 30 AIDS Clinical Trials Units (listed below), a Statistical and Data Management Center, and a Coordinating and Operations Center that will administer the Adult ACTG, provide scientific direction and perform advanced laboratory studies.
Because the NIAID and the National Institutes of Health are operating under a continuing budget resolution, funding amounts for the Adult ACTG awards will be determined as soon as possible after a final FY 1996 budget is approved.
The ACTG was established by NIAID in 1987 and remains the largest network of its kind in the world. The specific goals of the Adult ACTG are to:
* evaluate innovative therapeutic strategies and interventions to control HIV infection and its complications;
* facilitate rapid translation of basic research into clinical research and clinical practice; and
* provide a flexible resource for state-of-the-art, multidisciplinary, multicenter clinical trials that address the goals and objectives of NIAID's therapeutics research agenda.
ACTG trials have been the source of most of the information currently available on how best to treat people with HIV infection and related diseases," says Anthony S. Fauci, M.D., NIAID director. "For example, ACTG studies led to the approval of four antiretroviral drugs for the treatment of HIV disease, and subsequent studies have illuminated how best to use these drugs. ACTG research also has defined the standard preventive therapies and treatments for many opportunistic infections."
The 30 clinical sites in the Adult ACTG receiving four-year funding include 28 of the 35 current Adult Clinical Trials Units and two sites that are not currently members of the Adult ACTG. Among the units receiving funding are three incumbent units at minority institutions. Current AIDS Clinical Trials Units not being renewed will receive phase-out funding for one year to ensure that patients currently enrolled in studies will be followed until these studies are completed.
The Adult ACTG will be under the direction of Robert T. Schooley, M.D., of the University of Colorado Health Sciences Center, the chair of the Adult ACTG Executive Committee, and Constance A. Benson, M.D., of Rush-Presbyterian/St. Luke's Medical Center in Chicago, the vice chair of the Adult ACTG Executive Committee.
"As a group, the investigators of the Adult ACTG bring a wealth of expertise and experience to AIDS clinical research," says Dr. Schooley. "The Adult ACTG promises to be an extraordinary resource for assessing state-of-the-art therapies for HIV-infected people, and for studying the pathogenesis of HIV disease in its native host."
Dr. Schooley will also direct the Adult ACTG Coordinating and Operations Center at Social and Scientific Systems Inc., Rockville, Md. Also receiving funding is the Adult ACTG Statistical and Data Management Center, headed by Stephen Lagakos, Ph.D., at the Harvard School of Public Health.
The ACTG is an outgrowth of NIAID's first major programs for the evaluation of potential treatments for people with AIDS, which began in the summer of 1986. The original 36 AIDS Clinical Trials Units included two sites that enrolled children with AIDS. Additional pediatric sites were added between 1988 and 1989, and again in 1992. After a competitive renewal in 1992, the ACTG grew to include 35 adult and 22 pediatric AIDS Clinical Trials Units, in addition to a Statistical and Data Analysis Center, and an Operations Office.
More than 35,000 adults and more than 6,000 children and adolescents have enrolled in ACTG clinical trials ranging from early, single-site safety studies to large-scale, multicenter efficacy trials.
In 1993, NIAID conducted a comprehensive evaluation of the ACTG to assess its mission, scientific agenda and future direction, as well as the group's organizational structure and efficiency. This review was carried out by an external scientific review panel that evaluated the ACTG's scientific plans, and an NIAID staff working group that assessed organizational and managerial issues. Both review groups recommended that the leadership of the ACTG be strengthened, giving it increased authority and accountability for development and management of its scientific program. The reviewers also recommended that the ACTG place greater emphasis on pathogenesis-based clinical research.
These recommendations and others, including the separation of the Adult ACTG from the Pediatric ACTG, were incorporated into a Request for Applications for the competitive renewal of the Adult ACTG, published in August 1994. Three types of applications were solicited: for prospective AIDS Clinical Trials Units, for a Coordinating and Operations Center, and for a Statistical and Data Management Center.
Two separate committees were convened to review the three types of applications -- one panel reviewed the Coordinating and Operations Center and the Statistical and Data Management Center applications, which contained information on the group's overall scientific plans and management, and another reviewed the applications for clinical sites. Applications recommended for further consideration went through a second level of external peer review, by the National Advisory Allergy and Infectious Diseases Council, before a final decision was made on the sites that would be funded. Among the criteria considered in the review process were the scientific and technical merit of the applications, the qualifications of key personnel, experience in multicenter HIV/AIDS clinical research, adequacy of plans for inclusion of women and minorities, and a demonstrated ability to accrue a certain number of patients each year.
"With this redesign and peer review, the Adult ACTG is well-positioned to carry out its comprehensive research agenda of high priority studies in response to changing scientific opportunities," says Jack Killen, M.D., director of NIAID's Division of AIDS. "A new organizational flexibility, in combination with extraordinary scientific expertise, should enable the Adult ACTG to more effectively and efficiently pursue its research goals related to primary disease therapeutics, immune-based therapeutics/immune reconstitution, and the treatment and prevention of HIV-related opportunistic infections and other complications resulting from HIV disease."
In addition to the Adult ACTG and the Pediatric ACTG, NIAID supports three other clinical trials programs:
* the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), which conducts phase II and phase III trials, largely in primary care settings;
* the Division of AIDS Treatment Research Initiative (DATRI), which conducts innovative or intensive studies not easily performed within the ACTG or CPCRA; and
* the NIAID Division of Intramural Research, which focuses primarily on intensive clinical/laboratory investigations involving novel agents or modalities.
NIAID is a component of the National Institutes of Health. NIAID conducts and supports research aimed at preventing, diagnosing and treating illnesses such as AIDS and other sexually transmitted diseases, tuberculosis, asthma and allergies. NIH is an agency of the U.S. Public Health Service, part of the Department of Health and Human Services. ###
ADULT AIDS CLINICAL TRIALS UNITS and PRINCIPAL INVESTIGATORS (LISTED BY STATE OR TERRITORY)
ALABAMA University of Alabama at Birmingham Michael Saag, M.D.
CALIFORNIA Stanford University Thomas Merigan, M.D.
University of California at Los Angeles Ronald Mitsuyasu, M.D.
University of California at San Diego Douglas Richman, M.D.
University of California at San Francisco Mark Jacobson, M.D.
University of Southern California John Leedom, M.D.
COLORADO University of Colorado Robert Schooley, M.D.
DISTRICT OF COLUMBIA Howard University Robert Delapenha, M.D.
FLORIDA University of Miami Margaret Fischl, M.D.
HAWAII University of Hawaii Cecilia Shikuma, M.D.
ILLINOIS Northwestern University John Phair, M.D.
INDIANA Indiana University Joseph Wheat, M.D.
LOUISIANA Tulane University Juan Lertora, M.D., Ph.D.
MARYLAND Johns Hopkins University John G. Bartlett, M.D.
MASSACHUSETTS Massachusetts General Hospital Martin Hirsch, M.D.
MINNESOTA University of Minnesota Henry Balfour, M.D.
MISSOURI Washington University William Powderly, M.D.
NEW YORK Mount Sinai School of Medicine Henry Sacks, Ph.D., M.D.
New York University Fred Valentine, M.D.
Sloan-Kettering Institute Susan Krown, M.D.
University of Rochester Richard Reichman, M.D.
NORTH CAROLINA Duke University John A. Bartlett, M.D.
University of North Carolina at Chapel Hill Charles Van der Horst, M.D.
OHIO Case Western University Michael Lederman, M.D.
Ohio State University Robert Fass, M.D.
University of Cincinnati Peter Frame, M.D.
PENNSYLVANIA University of Pennsylvania Harvey Friedman, M.D.
PUERTO RICO University of Puerto Rico Guillermo Vazquez, M.D.
TEXAS University of Texas Health Science Center at Galveston Richard Pollard, M.D.
WASHINGTON University of Washington Ann Collier, M.D.
A question-and-answer document on the competitive renewal of the Adult AIDS Clinical Trials Group is available from the NIAID Office of Communications, telephone (301)-402- 1663