NIAID RESEARCH ON THE ACQUIRED IMMUNODEFICIENCY SYNDROME
The National Institute of Allergy and Infectious Diseases is the principal agency of the U.S. Public Health Service that is responsible for carrying out basic research and pathogenesis studies of HIV (the virus that causes AIDS), developing and testing new therapies and experimental vaccines for HIV, and conducting epidemiology studies among various populations affected by the epidemic.
NIAID sponsors studies through research project grants, contracts, and cooperative agreements. Several major contracts provide critical resources to NIAID and to researchers nationally. These contracts include the AIDS Research and Reference Reagent Program, which makes research reagents available to basic researchers, and the AIDS Clinical Trials Information Service, whose staff advises telephone callers on the status of AIDS clinical trials.
Scientists in NIAID's intramural laboratories are conducting basic research in such areas as molecular biology, virology, microbiology, and immunology. In addition, NIAID scientists carry out clinical research -- investigating promising new therapies and testing potential vaccines.
Basic research in a wide range of fields has laid the foundation for the many rapid advances that have contributed to our knowledge of HIV and AIDS. NIAID scientist have undertaken landmark studies in this area, including the recent discovery of lymphoid tissue as a major reservoir for HIV, and the demonstration that so-called clinical latency in fact is a period of active viral replication.
Multidisciplinary studies aim to increase understanding of the biology of HIV, including the life cycle of the virus and its effects on the host. Knowledge gained from these studies enhances the ability of researchers to create new agents and vaccines to combat HIV infection. The Centers for AIDS Research, established at U.S. research institutions and universities, provide core resources and enhance collaboration in AIDS-related research.
Researchers are studying HIV to find out how to interfere with the normal functioning of the virus. Finding new ways to inhibit HIV's ability to reproduce itself or ways to block its ability to integrate itself into the human genome will enable investigators to design novel agents and new drug combinations. Preclinical drug discovery and development involves the use of various animal models of retroviral infection to test potential new drugs to treat people with AIDS and its associated diseases -- the opportunistic infections and malignancies that are significant causes of sickness and death in AIDS patients.
Vaccine Research and Development
The development of a safe and effective vaccine for AIDS is a public health priority and a key goal of NIAID-supported research. Basic research studies are expanding knowledge of the mechanisms of immunity to HIV as well as providing information on the most promising candidate vaccines. NIAID- supported animal studies are examining the effects of a wide range of potential vaccines in several retroviral models. Other research focuses on the identification of vaccine adjuvants, compounds that enhance the response to the vaccine. Experimental vaccines in various stages of development include those consisting of killed or inactivated whole virus, synthetic peptides, anti-idiotypes, pseudoviruses or particles, and recombinant vectors. In the U.S., 11 of these vaccines are currently being evaluated in people for safety and the ability to stimulate the immune system. Clinical trials are being conducted in NIAID's Division of Intramural Research and at five AIDS Vaccine Evaluation Units located at universities throughout the United States.
NIAID's treatment research includes three networks for conducting multicenter clinical trials, which evaluate promising AIDS therapies. NIAID established the AIDS Clinical Trials Group in 1987, and the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) in 1989, to coordinate and foster collaboration in AIDS clinical trials. The Division of AIDS Treatment Research Initiative (DATRI) is a third clinical trials mechanism, which is designed to complement the ACTG and the CPCRA by addressing critical research questions that fall outside of their immediate priorities. In addition, clinical studies are carried out by researchers in the Division of Intramural Research.
Currently, 61 AIDS Clinical Trials Units (ACTUs), located in 20 states, the District of Columbia, and Puerto Rico, conduct large, multicenter clinical trials as well as some smaller single- and multi-institutional studies. Among the ACTUs, 24 conduct clinical trials exclusively in children; some of the adult ACTUs also participate in pediatric studies. In addition, the National Hemophilia Foundation participates in the ACTG through its Hemophilia Treatment Centers.
The CPCRA was established by NIAID to enlist community-based health care providers and their patients, particularly those who have been underrepresented in AIDS research, in studies of promising experimental AIDS therapies and in the development of new research methods appropriate to community settings. There are now 17 community programs operating in 13 U.S. cities, with some 160 affiliated clinical sites.
NIAID-sponsored epidemiologic studies strive to characterize and provide data on the clinical history of HIV infection and related diseases, develop the knowledge base for vaccine and treatment interventions, and identify the mechanisms of HIV transmission. Several large, multicenter epidemiologic research projects are under way. These important studies document the course of the disease in various populations and produce critical information on HIV transmission.