The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a new research collaboration representing a merger of investigators from the Pediatric AIDS Clinical Trials Group (PACTG) and the Perinatal Scientific Working Group of the HIV Prevention Trials Network (HPTN). The mission of the IMPAACT Network will be to significantly decrease the mortality and morbidity associated with HIV disease in pregnant women, children, and adolescents. We propose to establish a Philadelphia IMPAACT Clinical Trials Unit (PICTU) that will affiliate, by prior leadership agreement, as a priority site within the IMPAACT Network. This CTU will be comprised of an Administrative Component, two pediatric clinical research sites at the Children's Hospital of Philadelphia and St. Christopher's Hospital for Children, and a maternal/perinatal site at the Drexel University College of Medicine/Hahnemann University Hospital. The PICTU will respond to all four priority research areas identified by the IMPAACT leadership including: 1) Vaccine Research and Development, 2) Translational Research and Drug Development, 3) Optimization of Clinical Management including Co-Morbidity, and, 4) Prevention of Mother-to-Child Transmission of HIV. The PICTU will serve as a domestic unit within the Network. The PICTU is positioned to meet the enrollment requirements for the IMPAACT network. In 2004, there were 453 HIV-infected children and youth between 0 and 24 years of age, nearly all of whom are served by our pediatric sites. The Philadelphia HIV community is well-organized and highly-motivated to support the transition to new HIV/AIDS trial networks in the region and PICTU investigators have established ties with local community organizations and action groups. The PI, participating investigators, and senior professional staff have broad experience and success in the enrollment and retention of pregnant women, infants, children, and adolescents in HIV clinical trials, as well as a strong past record of leadership and scientific contributions in NIH-sponsored HIWAIDS research and within the PACTG and other HIV/AIDS research networks (REACH, ATN, HPTN). The proposed clinical research sites and their personnel have collaborated successfully as a PACTG unit in the past and have demonstrated a consistently excellent record of regulatory compliance, timely data submission, data management, and enrollment. The participating clinical research sites have demonstrated expertise in design of randomized controlled clinical treatment trials, pharmacokinetic, immunologic, virologic, and pharmacologic studies and are well-qualified to conduct IMPAACT protocols and contribute to the Network's scientific agenda. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-DDS-A (M1))
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Castillo, Blanca E
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Children's Hospital of Philadelphia
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Li, Binglan; Verma, Shefali S; Veturi, Yogasudha C et al. (2018) Evaluation of PrediXcan for prioritizing GWAS associations and predicting gene expression. Pac Symp Biocomput 23:448-459
Verma, Anurag; Bradford, Yuki; Verma, Shefali S et al. (2017) Multiphenotype association study of patients randomized to initiate antiretroviral regimens in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 27:101-111
Verma, Shefali S; Frase, Alex T; Verma, Anurag et al. (2016) PHENOME-WIDE INTERACTION STUDY (PheWIS) IN AIDS CLINICAL TRIALS GROUP DATA (ACTG). Pac Symp Biocomput 21:57-68
Fuchs, Jonathan D; Frank, Ian; Elizaga, Marnie L et al. (2015) First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090). Open Forum Infect Dis 2:ofv082
McGuire, Jennifer L; Gill, Alexander J; Douglas, Steven D et al. (2015) Central and peripheral markers of neurodegeneration and monocyte activation in HIV-associated neurocognitive disorders. J Neurovirol 21:439-48
Moore, Carrie B; Verma, Anurag; Pendergrass, Sarah et al. (2015) Phenome-wide Association Study Relating Pretreatment Laboratory Parameters With Human Genetic Variants in AIDS Clinical Trials Group Protocols. Open Forum Infect Dis 2:ofu113
Lehmann, David S; Ribaudo, Heather J; Daar, Eric S et al. (2015) Genome-wide association study of virologic response with efavirenz-containing or abacavir-containing regimens in AIDS clinical trials group protocols. Pharmacogenet Genomics 25:51-9
Wanga, Valentine; Venuto, Charles; Morse, Gene D et al. (2015) Genomewide association study of tenofovir pharmacokinetics and creatinine clearance in AIDS Clinical Trials Group protocol A5202. Pharmacogenet Genomics 25:450-61
McGuire, Jennifer L; Kempen, John H; Localio, Russell et al. (2015) Immune markers predictive of neuropsychiatric symptoms in HIV-infected youth. Clin Vaccine Immunol 22:27-36
Vardhanabhuti, Saran; Ribaudo, Heather J; Landovitz, Raphael J et al. (2015) Screening for UGT1A1 Genotype in Study A5257 Would Have Markedly Reduced Premature Discontinuation of Atazanavir for Hyperbilirubinemia. Open Forum Infect Dis 2:ofv085

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