TUBERCULOSIS PREVENTION IN CHILDREN TWO TO LESS THAN 13 YEARS OF AGE WITH AND WITHOUT HIV

Westat, Inc., Rockville MD

Investigators

Abstract

IMPAACT Related Study – Protocol 2024 –Tuberculosis – Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined with Isoniazid (1hp) for Tuberculosis Prevention in Children Two To Less Than 13 Years of Age with and Without HIV 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. 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 AIDS Clinical Trials Group (ACTG) and subsequently, in 1996 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. For the last 35 years, NICHD and the National Institute of Allergy and Infectious Diseases (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 curb 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 antiretroviral 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 plus the potential use of passive immunotherapy plus long-term acting antiretroviral therapy and even therapeutic vaccines.