This is a competitive renewal application for The Philadelphia Pediatric AIDS Clinical Trials Unit (PACTU), a consortium consisting of The Children's Hospital of Philadelphia (CHOP) as the main unit and a site for pediatric studies, St. Christopher's Hospital for Children (SCHC) as a pediatric subunit, and the Hospital of the University of Pennsylvania (HUP) and Temple University Hospital (TUH) as perinatal subunits. The Philadelphia PACTU has achieved a strong performance record over the past four years, with enrollments into Pediatric AIDS Clinical Trials Group (PACTG) clinical trials increasing from 24 during the first year of operation to 63 during year 4. The Philadelphia PACTU has had excellent success in entering patients into primary therapy, opportunistic infection, perinatal transmission, adolescent, quality- of-life, and immune-based therapy protocols, including many Phase I studies. In the past two years, an aggressive effort to promote participation in perinatal studies has resulted in a dramatic increase in the number of subjects enrolled into perinatal protocols. The Philadelphia PACTU has an outstanding record of administrative performance and compliance with regulatory and data management procedures. Several members of the Philadelphia PACTU hold leadership positions in the PACTG and are making major contributions to the scientific agenda, particularly with regard to immune-based prevention and treatment of HIV-infection in children. It is anticipated that, over the next four years, the Philadelphia PACTU will continue to: 1) enroll subjects into high priority protocols; 2) enroll an increased number of subjects into pediatric and perinatal protocols, including Phase I studies; 3) maintain its excellent record of compliance with regulatory and data management procedures; and 4) contribute in a major way to the scientific agenda of the PACTG.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI032921-07
Application #
2667733
Study Section
Special Emphasis Panel (ZAI1-OTP-A (01))
Project Start
1992-03-01
Project End
2001-02-28
Budget Start
1998-03-01
Budget End
1999-02-28
Support Year
7
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Children's Hospital of Philadelphia
Department
Type
DUNS #
073757627
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Saitoh, Akihiko; Capparelli, Edmund; Aweeka, Francesca et al. (2010) CYP2C19 genetic variants affect nelfinavir pharmacokinetics and virologic response in HIV-1-infected children receiving highly active antiretroviral therapy. J Acquir Immune Defic Syndr 54:285-9
Campbell, D E; Lai, J P; Tustin, N B et al. (2010) Analytical and biological considerations in the measurement of cell-associated CCR5 and CXCR4 mRNA and protein. Clin Vaccine Immunol 17:1148-54
Aldrovandi, Grace M; Chu, Clara; Shearer, William T et al. (2009) Antiretroviral exposure and lymphocyte mtDNA content among uninfected infants of HIV-1-infected women. Pediatrics 124:e1189-97
Saitoh, Akihiko; Haas, Richard H; Naviaux, Robert K et al. (2008) Impact of nucleoside reverse transcriptase inhibitors on mitochondrial DNA and RNA in human skeletal muscle cells. Antimicrob Agents Chemother 52:2825-30
Fletcher, Courtney V; DeVille, Jaime G; Samson, Pearl M et al. (2007) Nonlinear pharmacokinetics of high-dose recombinant fusion protein CD4-IgG2 (PRO 542) observed in HIV-1-infected children. J Allergy Clin Immunol 119:747-50
Saitoh, Akihiko; Sarles, Elizabeth; Capparelli, Edmund et al. (2007) CYP2B6 genetic variants are associated with nevirapine pharmacokinetics and clinical response in HIV-1-infected children. AIDS 21:2191-9
Saitoh, Akihiko; Fletcher, Courtney V; Brundage, Richard et al. (2007) Efavirenz pharmacokinetics in HIV-1-infected children are associated with CYP2B6-G516T polymorphism. J Acquir Immune Defic Syndr 45:280-5
Saitoh, Akihiko; Singh, Kumud K; Sandall, Sharsti et al. (2006) Association of CD4+ T-lymphocyte counts and new thymic emigrants in HIV-infected children during successful highly active antiretroviral therapy. J Allergy Clin Immunol 117:909-15
Shearer, William T; DeVille, Jaime G; Samson, Pearl M et al. (2006) Susceptibility of pediatric HIV-1 isolates to recombinant CD4-IgG2 (PRO 542) and humanized mAb to the chemokine receptor CCR5 (PRO 140). J Allergy Clin Immunol 118:518-21
Saitoh, Akihiko; Powell, Christine A; Fenton, Terence et al. (2004) Longitudinal analysis of lymphocyte ratios and HIV-1 intracellular DNA levels in children. J Infect Dis 189:1216-20

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