Clinical and Translational Investigation Core

The overarching aim of the Clinical and Translational Investigation Core (CTIC) is to facilitate the ability of CFAR investigators to initiate or expand HIV/AIDS research by providing a clinical and translational research platform that creates synergy across a wide range of disciplines. Two major Core services designed to meet this aim are a powerful web-based IRB compliant relational database that integrates clinical, laboratory and treatment information from HIV inpatient and outpatient visit electronic medical records and a CFAR biorepository of serial plasma, PBMCs and cervical-vaginal lavage fluid samples obtained from individuals newly-diagnosed with HIV, co-infected with HIV/HCV and elite controllers/long-term nonprogressors. 

 Core Mission   

• To provide a clinical and translational research relational database platform that enables basic, clinical, and behavioral researchers to access and leverage our extensive range of clinical and research cohorts for rigorous translational AIDS research. 
• To provide a biorepository that supports the research needs of CFAR investigators. 
• To identify epidemiologic trends in HIV disease outcomes in areas with high HIV prevalence by providing access to unique prospective cohorts of HIV-infected subjects.  
• To engage Bronx-based HIV community group leaders in designing and implementing clinical research studies.  
• To train early stage investigators in AIDS clinical and translational research, including consultation on grant applications. 
• To make current and future clinical and translational researchers aware of expertise, services, and training available through the CTIC; and to educate local HIV clinical providers about current evidence-based practice and new developments in HIV care. 

Core Facilities  

• A web-based IRB-compliant relational database that integrates clinical, laboratory and treatment information from the electronic medical records of almost 3,000 HIV-infected individuals. 
• An expanding biorepository of serial plasma, PBMCs and cervical-vaginal lavage fluid samples obtained from individuals either newly-diagnosed with HIV, co-infected with HIV/HCV and elite controllers/long-term nonprogressors. 
• A broad-based CFAR Community Advisory Board consisting of leaders of a wide array of Bronx-based HIV-related Community-based organizations that advises on how to facilitate community-based research studies. 

Core Services  

• A unified web-based clinical research database that facilitates synergistic research activity by combining data from diverse cohorts and specimen repositories into one centralized relational database  
• Access to CFAR biorepositories linked to a clinical database that includes serial samples from individuals newly infected with HIV, infected with HIV and HCV and elite controllers as well as other biorepositories of vaginal swabs, CVL, plasma, and PBMCs from over 300 women, including adolescents, HIV-infected and uninfected women, pregnant women, and post-coital samples of whom a subset also provided cervical or vaginal biopsies.  
• Access to data and samples from cohorts from Rwanda, Cameroon, Burundi and South Africa.  
• Support for the full-range of study design, initiation, implementation and evaluation including IRB submission, processes for enabling patient recruitment, enrollment and collection of historical information and data analysis and manuscript preparation     

Core Training Programs  

• Practical issues associated with conducting clinical and translational research 
• Good Clinical Practice (GCP),  
• Good Clinical Laboratory Practice (GCLP)  
• handling adverse events  
• managing data safety and monitoring boards 
• leading a research team 
• working with collaborators 
• Training in new technologies and laboratory techniques to enhance clinical and translational relevance.  
• Coordination of AIDS Center CFAR Grand Rounds   

Recent Core Publications 

Dusingize JC, Hoover DR, Shi Q, Mutimura E, Kierfer E, Cohen M, Anastos K.  Association of serum albumin with markers of nutritional status among HIV-infected and uninfected Rwandan women. PLoS One. 2012;7(4):e35079. PMCID: PMC3331977. 

Keller MJ, Malone AM, Carpenter CA, Lo Y, Huang M, Corey L, Willis R, Nguyen C, Kennedy S, Gunawardana M, Guerrero D, Moss JA, Baum MM, Smith TJ, Herold BC.  Safety and pharmacokinetics of aciclovir in women following release from a silicone elastomer vaginal ring. J Antimicrob Chemother. 2012. PubMed PMID: 22556381. 

Keller MJ, Madan RP, Torres NM, Fazzari MJ, Cho S, Kalyoussef S, Shust G, Mesquita PM, Louissaint N, Chen J, Cohen HW, Diament EC, Lee AC, Soto-Torres L, Hendrix CW, Herold BC.  A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel. PLoS ONE. 2011;6(1):e16475. PMCID: PMC3026837.   

Kierfer E, Hoover DR, Shi Q, Dusingize JC, Cohen M, Mutimura E, Anastos K.  Association of pre-treatment nutritional status with change in CD4 count after antiretroviral therapy at 6, 12, and 24 months in Rwandan women. PLoS One. 2011;6(12):e29625. PMCID: PMC3247268.  

Kuniholm MH, Gao X, Xue X, Kovacs A, Anastos K, Marti D, Greenblatt RM, Cohen MH, Minkoff H, Gange SJ, Fazzari M, Young MA, Strickler HD, Carrington M.  Human leukocyte antigen genotype and risk of HIV disease progression before and after initiation of antiretroviral therapy. Journal of Virology. 2011;85(20):10826-33. PubMed PMID: 21849458. 

Berg KM, Litwin AH, Li X, Heo M, Arnsten JH. Lack of sustained improvement in adherence or viral load following a directly observed antiretroviral therapy intervention. Clinical Infectious Diseases  2011;53:936-43. PMCID: PMC3189166. 

Cunningham CO, Sohler NL, Cooperman NA, Berg KM, Litwin AH, Arnsten JH. Strategies to improve access to and utilization of health care services and adherence to antiretroviral therapy among HIV-infected drug users. Subst Use Misuse. 2011;46:218-32. PMID: 21303242.  Nahvi S, Litwin AH, Heo M, Berg KM, Li X, Arnsten JH. Directly observed antiretroviral therapy eliminates adverse effects of active drug use on adherence. Drug Alcohol Depend. 2011. PubMed PMID: 21885212. 

Polsky S, Floris-Moore M, Schoenbaum EE, Klein RS, Arnsten JH, Howard AA. Incident hyperglycaemia among older adults with or at-risk for HIV infection. Antivir Ther. 2011;16:181-8. PMID: 21447867.