Pediatric Clinical Trials Program for AIDS

Baylor College Of Medicine, Houston TX

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The Pediatric AIDS Clinical Trials Group (PACTG) clinical trials site at Baylor College of Medicine (BCM), now in its 13th year of continual support from the National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID), is seeking renewed support for the years 2002 to 2007 in reply to the Request for Applications (RFA) AI-00-015. Based upon its past performance in carrying out the scientific agenda of the PACTG, as reflected in scientific contributions, publications, quality of data, numbers of patients enrolled in clinical trials, and participation of its Community Advisory Board, BCM should be able to succeed well in the new grant period. In the nearly 4-year period from the start of the current funding period (April 1997), BCM has made 345 patient enrollments into PACTG protocols, made significant contributions to the leadership and committee work of the PACTG, published over 60 scientific studies in peer-reviewed literature, and maintained an excellent quality of data. BCM began an Adolescent AIDS Initiative in 1999 with an incentive funding award from the NIAID to enroll adolescent children and young adults into PACTG protocols. A special clinic with late afternoon hours and several support systems have been put into place to capture this important patient population, as well as initiation of special education and support groups, treatment readiness programs, and participation in several camps. In addition to preparing for the adolescent scientific agenda of the PACTG, BCM has prepared itself to be able to make contributions to the primary therapy, perinatal, immunology/immune-based therapy, and complication of HIV scientific agendas. Examples of this dedication are its strong enrollments into perinatal research protocols (e.g., PACTG 316 and 358), development of novel immune-based therapy protocols (e.g., PACTG 351 recombinant CD4-IgG2) and the first large-scale study of lymphocyte phenotyping of children from birth through 18 years of age (P-1009), and large enrollment into PACTG protocol 219C to study possible toxic effects of antiretroviral drugs on HIV -1 exposed children. The combined strengths of several national and regional natural history trials (WITS program, PACTG Minority Faculty Award, PACTG Immunology Core Laboratory, HRSA program for women and children, Pediatric Spectrum of Disease project, NIAID Training Program for Clinical Research on AIDS, CFAR, and R01 awards [e.g., Cardiovascular Complications of HIV Infection]) with over 1OO participating professionals give BCM the potential to exceed its past strong role in carrying out the scientific agenda of the PACTG.