To expand the testing of promising therapies for patients with HIV -- the virus that causes AIDS and related illnesses -- the National Institute of Allergy and Infectious Diseases has added four institutions serving largely minority populations to its AIDS Clinical Trials Group, HHS Secretary Donna E. Shalala announced today. NIAID has also renewed 13 pediatric clinical trials sites and increased the group's laboratory capabilities, she said.
One of four such networks supported by NIAID, the ACTG is the largest network of clinical trials sites in the world. "These new awards will enhance our capability to meet our goal of developing the best and safest therapies for men, women and children with HIV," said Secretary Shalala. "This network is an essential part of the substantial efforts of the Department of Health and Human Services to contain this global epidemic."
In the United States, 284,840 adults and 4,480 children aged 13 and younger have developed AIDS as of March 31, 1993, according to the Centers for Disease Control and Prevention.
The new AIDS Clinical Trials Units at institutions serving predominantly minority populations will enroll adults at Howard University in Washington, D.C., Meharry Medical College in Nashville, Tenn., the University of Hawaii in Manoa, and the University of Puerto Rico in San Juan. Except for Meharry, these institutions previously participated in NIAID's AIDS Infrastructure for Minority Institutions Program, which provided technical assistance and support to develop and enhance the ability of institutions serving minority populations to conduct AIDS clinical trials. The new awards will total an estimated $3.6 million in FY 1993.
The expansion of the AIDS Clinical Trials Group to include these institutions will greatly augment our ability to enroll participants from the ethnic minorities, who have been so hard hit by the HIV epidemic," said Anthony S. Fauci, M.D., director of NIAID. "By taking part in clinical investigations, individuals from underrepresented populations contribute a great deal to our efforts to find safe and effective drugs and therapies to treat HIV disease and AIDS in a diversity of infected people. This action also will increase the number of minority investigators participating in AIDS research."
Of the 289,320 U.S. AIDS patients reported to CDC through the end of March 1993, 88,238 (30.5 percent) are black, 47,835 (16.5 percent) are Hispanic, 1,823 (.6 percent) are Asian/Pacific Islander and 569 (.2 percent) are American Indian or Alaskan Native.
In addition, NIAID renewed 13 pediatric sites. Another nine pediatric units were funded in 1992. One former pediatric unit at Boston City Hospital did not apply for renewal and has merged with the renewing unit at Children's Hospital in Boston, Mass. Almost 1,000 children and adolescents aged 18 and younger are expected to enroll in studies at the 22 units, with an additional 250 participants expected in ACTG studies supported by the National Institute of Child Health and Human Development.
The FY 1993 funding for the new pediatric units and the laboratory expansions of existing units will total about $22 million. Of the nine units funded in 1992, eight applied for and will receive support to expand their laboratory investigations. The new awards will provide support for 13 virology laboratories, three virology research projects, eight immunology laboratories, two immunology research projects, one neuropsychiatric research project and five pharmacology laboratories.
The renewal of these pediatric units and the expansion of laboratory facilities will enhance our capability to conduct and evaluate studies in children and adolescents infected with HIV," said Dr. Fauci.
The 13 renewing pediatric sites are:
The nine pediatric sites funded in 1992 are:
Sites designated with * received funding for laboratories or research projects.
When competing for funding, new or renewal, candidate clinical trials units are evaluated on their scientific, technical and laboratory strengths and expertise, cost effectiveness, potential patient populations and geographic balance within the entire Group. Incumbent units also are judged by their past performances.
The AIDS clinical trials effort dates to June 1986 when NIAID established 14 adult AIDS Treatment Evaluation Units. In 1987, this network expanded to include five new units and 17 new sites, called Clinical Study Groups. In December of that year, NIAID established the existing group, incorporating the existing units and study groups. Since 1986, approximately 23,000 people have participated in more than 190 studies.
In January 1992, NIAID streamlined the organization of the ACTG and added new units, allowing the enrollment of more patients with an emphasis on greater diversity of HIV-infected people, particularly women, minorities and injection drug users. The reorganization also permitted NIAID to conduct trials in the most efficient and cost-effective manner. Other changes included an incentive plan that ties funding to productivity, permitting NIAID to provide top-performing units with additional funds.
The group's trials have led to the approval of a number of AIDS-related therapies by the Food and Drug Administration, a Public Health Service agency. More than 30 drugs and drug combinations are under investigation.
Existing adult sites include:
NIAID is one of the 16 institutes of the National Institutes of Health, the federal focal point for health research and an agency of the Public Health Service, which is part of HHS.
NIAID's expert scientists study AIDS and HIV disease, tuberculosis, allergies, asthma, Lyme disease, transplantation and basic immunology with an emphasis on prevention, diagnosis and improved treatment. In addition to its laboratories in Bethesda, Md., and Hamilton, Mont., NIAID supports research and training of nonfederal scientists at universities, medical schools, hospitals and research institutions throughout the United States and abroad.
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