Translational Medical Research Commons^™

Research Support Infrastructure: Implementing A Clinical Research Coordinating Center, Julio A. Ramirez, Paula Peyrani, William A. Mattingly, Forest W. Arnold, Timothy L. Wiemken, Robert R. Kelley, Leslie A. Wolf, Ruth M. Carrico, Andrea Reyes-Vega

Faculty Scholarship

Insufficient infrastructure is one of the challenges facing investigators in the field of clinical research. At the University of Louisville (UofL) Division of Infectious Diseases, we developed a multidisciplinary coordinating center with the aim to support investigators in all aspects of the clinical research process. The objective of this article is to describe the composition and the role of the different units of the UofL Clinical Research Coordinating Center. The different components of the Center can serve as a template for institutions interested in developing a clinical research support infrastructure.

Gender Differences In Virologic Response After Antiretroviral Therapy In Treatment-Naïve Hiv-Infected Individuals: Results From The 550 Clinic Hiv Cohort Study., Andrea Reyes-Vega, Alejandra Loban, Kavitha Srinivasan, Stephen P. Furmanek, Conner English, Mary Bishop, Cathy Spencer, Daniel Truelove, Julio A. Ramirez, Anupama Raghuram, Paula Peyrani

Faculty Scholarship

Background

Controversy still exists regarding gender differences in virologic response between treatment-na•ve HIV-infected individuals. The objective of this study was to evaluate gender difference in virologic and immunologic response to antiretroviral therapy in treatment-na•ve HIV-infected individuals. Methods

This was a retrospective, observational study of treatment-na•ve HIV-infected individuals managed at the 550 clinic who started antiretroviral therapy (ART) between January 1st, 2010 and December 31, 2015. Patients with available viral load and CD4 counts before and one year after initiating ART were included in this study. Virologic suppression was defined as < 48 HIV-1 RNA copies/mL, and mmunologic recovery was defined as a CD4 count increase of at least 150 cells/mm3. Dichotomous variables were reported in number and percentages and analyzed using Chi-squared tests and Fisher’s exact (whichever was appropriate). Continuous variables were reported as median and interquartile range (IQR) and analyzed using Wilcox rank-sum tests. Multivariate analyses performed were logistic regressions with adjustment for other covariates. P value <0.05 was considered statistically significant. R version 3.3.2 was used for the statistical analysis. Results

A total of 70 women and 90 men were included …