Abstract

This application is a proposal to serve as the Statistical and Data Management Center of the Pediatric AIDS Clinical Trials Group (PACTG), in affiliation with the PACTG Central Group headed by Dr. Stephen Spector. Our overall objectives and aims are to be responsible for all statistical and data management activities of the PACTG, including: (1) providing statistical leadership in the design and analysis of PACTG studies; (2) establishing and administering a central data management system; (3) collaborating with PACTG investigators on scientific and procedural issues and long-range planning, (4) conducting secondary and cross-study database analyses, and (5) conducting statistical research on issues central to the PACTG's mission. The SDMC is accountable to the PACTG Group Chair and the Pediatric Executive Committee. To ensure that our responsibilities are completed in a timely manner and yield products of high quality, we have (1) established statistical and data management centers, each governed by a well-defined management, administrative and organizational structure that parallels and facilitates interactions with the PACTG protocol teams and committees; and (2) assembled a staff of highly-qualified and experienced clinical trial specialists.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01AI041110-01
Application #
2005649
Study Section
Special Emphasis Panel (ZAI1-MCH-A (03))
Project Start
1997-03-01
Project End
2001-02-28
Budget Start
1997-03-01
Budget End
1998-02-28
Support Year
1
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
Harvard University
Department
Type
Schools of Public Health
DUNS #
082359691
City
Boston
State
MA
Country
United States
Zip Code
02115

  Publications

Chernoff, Miriam; Angelidou, Konstantia Nadia; Williams, Paige L et al. (2018) Assessing Psychiatric Symptoms in Youth Affected by HIV: Comparing a Brief Self-Administered Rating Scale with a Structured Diagnostic Interview. J Clin Psychol Med Settings 25:420-428
Jacobson, Denise L; Lindsey, Jane C; Coull, Brent A et al. (2018) The Association of Fat and Lean Tissue With Whole Body and Spine Bone Mineral Density Is Modified by HIV Status and Sex in Children and Youth. Pediatr Infect Dis J 37:71-77
Zeldow, B; Kim, S; McSherry, G et al. (2017) Use of antiretrovirals in HIV-infected children in a tuberculosis prevention trial: IMPAACT P1041. Int J Tuberc Lung Dis 21:38-45
Bellavia, Andrea; Williams, Paige L; DiMeglio, Linda A et al. (2017) Delay in sexual maturation in perinatally HIV-infected youths is mediated by poor growth. AIDS 31:1333-1341
Kapogiannis, Bill G; Leister, Erin; Siberry, George K et al. (2016) Prevalence of and progression to abnormal noninvasive markers of liver disease (aspartate aminotransferase-to-platelet ratio index and Fibrosis-4) among US HIV-infected youth. AIDS 30:889-98
Sirois, Patricia A; Aaron, Lisa; Montepiedra, Grace et al. (2016) Stimulant Medications and Cognition, Behavior and Quality of Life in Children and Youth with HIV. Pediatr Infect Dis J 35:e12-8
Livingston, Elizabeth G; Huo, Yanling; Patel, Kunjal et al. (2016) Complications and Route of Delivery in a Large Cohort Study of HIV-1-Infected Women-IMPAACT P1025. J Acquir Immune Defic Syndr 73:74-82
Katz, Ingrid T; Leister, Erin; Kacanek, Deborah et al. (2015) Factors associated with lack of viral suppression at delivery among highly active antiretroviral therapy-naive women with HIV: a cohort study. Ann Intern Med 162:90-9
Best, B M; Burchett, S; Li, H et al. (2015) Pharmacokinetics of tenofovir during pregnancy and postpartum. HIV Med 16:502-11
Kacanek, Deborah; Angelidou, Konstantia; Williams, Paige L et al. (2015) Psychiatric symptoms and antiretroviral nonadherence in US youth with perinatal HIV: a longitudinal study. AIDS 29:1227-37

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