UCLA and the David Geffen School of Medicine at UCLA are among 60 U.S. and international institutions selected to receive funding as HIV/AIDS clinical trials units from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The university and the Geffen School of Medicine were each awarded one clinical trials unit. The UCLA unit is for adult treatment, with trials to be conducted at sites in Los Angeles, while the medical school's unit will focus on prevention of mother-to-child HIV transmission, treatment and prevention in children and adolescents, and international adult prevention and treatment trials, with sites in Los Angeles and Brazil.
The 60 new clinical trials units are part of a newly restructured NIAID system that includes six HIV/AIDS clinical research networks. The clinical trials units will conduct prevention and treatment research in collaboration with these networks. NIAID expects to fund 13 more units over the next few months, bringing the total to 73.
"This funding will strengthen our efforts to improve treatment options both locally and internationally," said Dr. Judith Currier, co-director of the UCLA Center for Clinical AIDS Research and Education (CARE), a member of the UCLA AIDS Institute and principal investigator for the UCLA adult clinical trials unit.
Dr. Eric Daar, chief of HIV medicine at Harbor-UCLA Medical Center, is the co-principal investigator for the adult unit.
The principal investigator for the other unit will be Dr. Yvonne Bryson, chief of pediatric infectious diseases at the David Geffen School of Medicine at UCLA and chair of the perinatal-women's health committee of the NIH's International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) leadership group. Bryson's co-principal investigator is Dr. Karin Nielsen, associate clinical professor of pediatric infectious diseases at the Geffen School of Medicine and a member of the IMPAACT scientific oversight committee.
Dr. Jaime Deville, UCLA associate clinical professor of pediatric infectious diseases, will be the principal investigator for the UCLA Care 4 Families research site.
"This funding provides new opportunities for global involvement," Bryson said.
NIAID supports the world's largest HIV/AIDS clinical research effort.
The selection of clinical trials units represents the second step of a two-part restructuring process of NIAID's HIV/AIDS clinical trials networks. NIAID announced the clinical investigators and institutions responsible for leading the new networks in June 2006 (For more information, visit www3.niaid.nih.gov/news/newsreleases/2006/leadership.htm).
Each clinical trials unit is a member of one or more of NIAID's six HIV/AIDS networks: the AIDS Clinical Trials Group, the HIV Prevention Trials Network, the HIV Vaccine Trials Network, the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, the International Network for Strategic Initiatives in Global HIV Trials, and the Microbicide Trials Network.
The HIV/AIDS networks and their clinical trials units will pursue an integrated research approach to conducting clinical trials designed to address the highest priorities in HIV/AIDS research, including:
. Developing a safe and effective HIV vaccine.
. Conducting research for new drug development designed to translate lab findings into clinical applications.
. Optimizing clinical management of HIV/AIDS, including co-infections and other HIV-related conditions.
. Developing microbicides to prevent HIV acquisition and transmission.
. Creating strategies to prevent mother-to-child HIV transmission.
. Developing new methods of HIV prevention.
Each clinical research unit is led by a principal investigator and includes an administrative component, community advisory board and one or more clinical research sites - including medical schools, academic health centers, hospitals and outpatient clinics - where studies will be conducted. A list of principal investigators and clinical research sites can be found at www3.niaid.nih.gov/about/organization/daids/Networks/daidsnetworkunits.htm.
The U.S.-based units will be located in the following states and territories: Alabama, California, Colorado, Florida, Georgia, Illinois, Maryland, Massachusetts, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, Washington state and Puerto Rico. Additional units are expected in Louisiana and Washington, D.C.
The units located outside the United States are in the Dominican Republic, Haiti, Jamaica, Peru, South Africa, Switzerland, Brazil and Thailand. Additional units are anticipated in China, France and India.
The 145 clinical research sites where trials will be performed may be located in different states or countries than the clinical trials units with which they are affiliated. In addition to the locations noted above, clinical research sites are also anticipated in Michigan, Oklahoma, Rhode Island and Virginia, and internationally in Botswana, Malawi, Panama, Tanzania, Uganda, Vietnam, Zambia and Zimbabwe.
UCLA's clinical research sites are at the UCLA CARE Center and the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. The Geffen School of Medicine research sites include the UCLA Medical Center Care 4 Families center, as well as three hospitals in Brazil where UCLA researchers conduct extensive work - Hospital Conceição and Santa Casa Hospital, both in Porto Alegre, and Hospital dos Servidores do Estado in Rio de Janeiro.
"This is a culmination of many years of being involved in clinical trials," Bryson said, adding "this will allow us to expand our work in Brazil."
The selection process for the clinical trials units involved a rigorous and extensive scientific peer review of the units' proposed clinical programs and capabilities, including access to populations most affected or threatened by the HIV/AIDS epidemic, particularly women, children, adolescents and people of diverse ethnic or racial backgrounds.
Total funding for the clinical trials networks and the clinical trials units and their affiliated research sites is expected to reach $285 million during the first year of the awards. This also includes funding for previously existing clinical trials units and clinical research sites, which will allow them to continue their participation in ongoing studies for a long enough period of time to ensure that there are no gaps in current HIV/AIDS research studies.
Planning for the NIAID network restructuring began in October 2001 with extensive consultations between NIAID staff and other researchers, clinicians, patient advocates and people living with or at risk for developing HIV/AIDS.
The NIAID HIV/AIDS clinical trials networks are also co-funded and supported by a number of other National Institutes of Health institutes and centers that conduct collaborative research studies with the networks.
For additional information about NIAID network and the HIV/AIDS clinical trials units, visit www3.niaid.nih.gov/news/QA/CTU07QA.htm.
Established in 1992, the UCLA AIDS Institute is a multidisciplinary think tank drawing on the skills of top-flight researchers in the worldwide fight against HIV and AIDS, the first cases of which were reported in 1981 by UCLA physicians. Institute members include researchers in virology and immunology, genetics, cancer, neurology, ophthalmology, epidemiology, social science, public health, nursing, and disease prevention. Their findings have led to advances in treating HIV as well as other diseases, such as hepatitis B and C, influenza, and cancer.
The National Institute of Allergy and Infectious Diseases is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria, and illnesses from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH) - the nation's medical research agency - includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures of both common and rare diseases. For information on the NIH and its programs, visit www.nih.gov.
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