The overall objective of this proposal is to establish clinical research sites for three HIV/AIDS Clinical Trials Networks: Vaccine Research and Development, HIV Prevention, and Optimization of Clinical Management, including Co-morbidities.
The specific aims of the NCAIDS CTU are as follows: (1) To conduct clinical trials assessing the safety, immunogenicity, and efficacy of selected candidate HIV-1 vaccines in high-risk populations;(2)To conduct clinical trials evaluating the efficacy and acceptability of promising behavioral and biomedical intervention strategies for preventing HIV transmission in high risk populations;(3)To conduct clinical trials evaluating new therapies against HIV-infection or co-infections with the goal of optimizing the therapeutic effects, increasing medication adherence, elucidating novel mechanisms, and improving features in resistance and toxicological properties;(4)To ensure the clinical trial capability in China adheres to international standards and good clinical practices in order to evaluate strategies for prevention, intervention, and treatment of HIV infection;(5)To further develop the clinical trial infrastructure and enhance the expertise and skills of Chinese investigators, students, and staff to strengthen the HIV prevention and control efforts in China. The main population for the vaccine and prevention research will be intravenous;drug users living in Urumqi City in Xinjiang Autonomous Region, Longchuan County in Yunnan Province, and Shizhong District of Leshan City in Sichuan Province. Research for the optimization of clinical management will be conducted at Beijing Ditan Hospital, Beijing Youan Hospital, and Guangzhou Number 8 People's Hospital in Guangdong Province. These six proposed sites are qualified for implementing clinical trial protocols and have the capacity to enroll sufficient numbers of study subjects. By adhering to good clinical practices, standard operating procedures, and the study protocols, and conducting quality assurance and control measures, the clinical research in the proposed sites will be implemented well and will meet international standards. The HIV epidemic in China has begun to spread from high risk groups to the general population. China urgently needs to join international research aiming at finding new prevention and treatment methods against HIV. Successful implementation of clinical trials on HIV vaccine, behavioral and biomedical prevention, and treatment will greatly assist efforts to control and prevent HIV/AIDS in China and the rest of the world. ADMINISTRATIVE COMPONENT:
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