This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Suboptimal response to HBV in HIV-infected adults and children has been well documented in the literature. Given the importance of preventing HBV co-infection in HIV-infected youth and the findings of poor response in HIV-infected adolescents and young adults receiving the recommended dose and schedule within the REACH cohort, the Pediatric AIDS Clinical Trials Group (PACTG) will undertake a randomized clinical trial of three hepatitis B vaccination schemas in an attempt to improve sero-response and thus, achieve protection from HBV. This is a prospective, stratified, block-randomized, three-arm, open-label clinical trial of three groups with the standard adult Engerix B dose as Arm 1, a 2X standard dose Engerix B as Arm 2 and a combined hepatitis A/hepatitis B vaccine (Twinrix ) as Arm 3. Subjects will be HIV-infected adolescents and young adults (acquisition by any route) from age 12 to < 25 years who are either hepatitis B vaccine nanve or have received no more than one hepatitis B vaccine in the past and have negative Hepatitis B surface antibody at baseline. Patients will be randomized to one of the above regimens. The randomization will be blocked and stratified, with block size equal to 6. Absolute CD4+ T-lymphocyte cell count (<500 and >500) and previous HBV vaccination will define the strata. The randomization will be restricted so that the percentage of subjects with CD4+ T cell count < 200 cells/ml will not exceed 15% of subjects on each arm. The primary outcome, percentage sero-response, will be compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) in an intent-to-treat analysis.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000069-45
Application #
7605108
Study Section
Special Emphasis Panel (ZRR1-CR-9 (01))
Project Start
2007-03-01
Project End
2008-02-29
Budget Start
2007-03-01
Budget End
2008-02-29
Support Year
45
Fiscal Year
2007
Total Cost
$17,660
Indirect Cost
Name
University of Colorado Denver
Department
Pediatrics
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
Young, Kendra A; Maturu, Amita; Lorenzo, Carlos et al. (2018) The triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio as a predictor of insulin resistance, ?-cell function, and diabetes in Hispanics and African Americans. J Diabetes Complications :
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
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
Patel, Sonali S; Truong, Uyen; King, Martina et al. (2017) Obese adolescents with polycystic ovarian syndrome have elevated cardiovascular disease risk markers. Vasc Med 22:85-95

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