HIV AND OTHER IMPAACT RELATED INFECTIOUS DISEASE STUDIES

Westat, Inc., Rockville MD

Investigators

Abstract

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides clinical trial sites to the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). The IMPAACT network and its leadership group oversee the creation of all their studies, protocols, and clinical trials. These activities are funded through Grants/Cooperative agreements sponsored by NIAID. The IMPAACT Network is a cooperative group of institutions, investigators, and other collaborators mainly focused on evaluating potential therapies for HIV infection and its related symptoms and co-infections in infants, children, adolescents and pregnant women. This includes clinical trials of HIV/AIDS interventions for the prevention of mother to child transmission. The IMPAACT Network goal is to conduct high quality clinical trials and/or protocols that will advance the prevention and treatment of HIV and its complications for infants, children, adolescents, and pregnant/ postpartum women globally. The IMPAACT research agenda in this task order includes four scientific specific aims, which reflect the key areas of work. Those areas are HIV Treatment, HIV Prevention, HIV Cure, and HIV Complications. For each area, a Scientific Committee composed of experts in the specific field, site investigators, community representatives, and representatives of the central network resources, continually reassesses the research priorities in light of emerging science as well as new ideas and opportunities; it seeks collaboration with other trials networks and research entities; oversees the formulation and review of study concept plans based on the scientific priorities; and monitors the development and implementation of approved network studies in the specific research area. In 1990 the NICHD began collaborating with the Pediatric AIDS Clinical Trials Group (PACTG) to expand clinical trial availability at NICHD clinical trial centers/sites. This collaboration made possible to conduct clinical trials by the IMPAACT Network to further evaluate antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. In recent years, the collaboration is expanding to evaluate potential HIV cure approaches and vaccines. The purpose of this task order is to recruit, follow and complete the IMPAACT Related protocols listed below. The integration of the results of these 8 protocols, which will be presented in a final report, will provide data to advance the prevention, treatment and remission of HIV, its most common complications and related infectious diseases in maternal, adolescent and pediatric populations. For the last 35 years NICHD/NIAID as part of the scientific community have been conducting intense HIV research. During this time, it became clear that to be successful in the attempt to curve the HIV infection rates of the epidemic, and appropriately treat the individual infectious process, an integrated and comprehensive approach to HIV research is required. Furthermore, NICHD/NIAID and others in the scientific community found in the mid-90s that one or even two different anti-retroviral drugs (ARVs) are not sufficient to appropriately treat an individual HIV infection. Therefore, the synergy of three or more drugs (ARVs) is required to effectively treat and keep at bay an individual HIV infection. For that reason, the development and testing of multiple ARVs in different trials is essential. This requires the development and testing of multiple ARVs in different trials. At the same time, as soon as a drug was developed and approved, multiple other trials were needed to discern the potential synergy between them. It is now known to the scientific community, that the initial attempts to achieve an HIV Cure (remission) might require the interaction of multiple ARVs, in addition to an early start in the treatment after infection (clinical protocols in this task order) plus the potential use of passive immunotherapy plus long term acting antiretroviral therapy (under study in a task order protocol) and possibly even therapeutic vaccines. Therefore, it is evident that although all individual trials (protocols) can provide very useful information, the integration of this acquired knowledge from some of the different protocols will provide a more comprehensive data analysis that will lead to a better scientific assessment to determine the best approach for prevention and treatment of HIV and its complications and comorbidities in the maternal, adolescent and pediatric populations. While the individual protocols are important, completion of the 8 protocols in this task order and receipt of the final report, which includes the integrated data from all these protocols, is necessary because if not NICHD and the IMPAACT Network may lose part of the comprehensive nature of these studies. It is also evident that combined results could eventually help in the process of achieving a better and sustained HIV remission, and a more effective prevention and treatment for HIV and other related infectious diseases in pediatric, adolescent, and maternal patient populations.