An estimated 1 million Americans (and more than 90,000 New York City residents) have HIV infection. Despite recent advances, HIV/AIDS remains an important area for clinical investigation. This application describes the Cornell Clinical Trials Unit (CCTU), an HIV/AIDS therapeutic clinical trials unit that will affiliate with the 3 AIDS Clinical Trials Group (ACTG) network by prior agreement. The Cornell unit consists of an overall administrative core and two CRSs: Cornell Uptown and Cornell Chelsea. The core unit provides central research support to the CRSs including: investigative oversight, administration, study coordination, data management, regulatory, outreach, and pharmacy services. The two clinical research sites CRSs are located in different parts of New York City, in or close to the neighborhoods with the highest HIV seroprevalence rates: Cornell Uptown is located close to East Harlem (2.5% seroprevalence) and Cornell Chelsea is located in Chelsea-Clinton (4.1% seroprevalence). The two CRSs serve distinct patient populations that include significant numbers of women, people of color (African Americans, Asians, and Latinos), and adolescents/young adults from diverse risk groups (heterosexuals, injection drug users, men who have sex with men). With 17 years experience in the ACTG, the Cornell unit has broad scientific and clinical research experience in diverse areas including: antiretroviral agents and strategies;complications of HIV and antiretroviral therapies;immune-based therapies, including vaccines;co-infections (e.g. hepatitis B, hepatitis C, and human papillomavirus);neurological complications;adherence and outcomes;HIV-infected women and pregnancy;and prevention of mother-to-child transmission of HIV. The Cornell unit will contribute to the priority research areas of the ACTG: translational research/drug development;optimization of clinical management, including co-morbidities;therapeutic vaccine research and development;and prevention of mother-to-child transmission. Cornell investigators serve in ACTG leadership positions, on ACTG committees, and ACTG protocol teams (including protocol leadership for 11 current studies). Cornell has strong ties to Haiti and plays an active role in mentoring and training Haitian HIV/AIDS clinical investigators. A major focus of the Cornell unit is community outreach and education and the Cornell Community Advisory Board is active in representing our diverse community. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI069419-06
Application #
8195398
Study Section
Special Emphasis Panel (ZAI1-BLG-A (M1))
Program Officer
Welsch, Sue A
Project Start
2007-01-10
Project End
2013-11-30
Budget Start
2011-12-01
Budget End
2012-11-30
Support Year
6
Fiscal Year
2012
Total Cost
$1,462,527
Indirect Cost
$592,284
Name
Weill Medical College of Cornell University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
060217502
City
New York
State
NY
Country
United States
Zip Code
10065
Simoni, Jane M; Huh, David; Wang, Yan et al. (2014) The validity of self-reported medication adherence as an outcome in clinical trials of adherence-promotion interventions: Findings from the MACH14 study. AIDS Behav 18:2285-90
Mollan, Katie R; Smurzynski, Marlene; Eron, Joseph J et al. (2014) Association between efavirenz as initial therapy for HIV-1 infection and increased risk for suicidal ideation or attempted or completed suicide: an analysis of trial data. Ann Intern Med 161:1-10
Zweifel, Vineeta Bansal; Berger, Christoph; Nadal, David et al. (2014) [HIV and pregnancy]. Ther Umsch 71:498-502
Lennox, Jeffrey L; Landovitz, Raphael J; Ribaudo, Heather J et al. (2014) Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med 161:461-71
Kuo, Irene; Golin, Carol E; Wang, Jing et al. (2014) Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend 139:93-9
Leger, Paul D; Johnson, Daniel H; Robbins, Gregory K et al. (2014) Genome-wide association study of peripheral neuropathy with D-drug-containing regimens in AIDS Clinical Trials Group protocol 384. J Neurovirol 20:304-8
Weinberg, Adriana; Bosch, Ronald; Bennett, Kara et al. (2014) Regulatory T cells and the risk of CMV end-organ disease in patients with AIDS. J Acquir Immune Defic Syndr 66:25-32
Zheng, Yu; Hughes, Michael D; Lockman, Shahin et al. (2014) Antiretroviral therapy and efficacy after virologic failure on first-line boosted protease inhibitor regimens. Clin Infect Dis 59:888-96
Vogler, Mary A; Smeaton, Laura M; Wright, Rodney L et al. (2014) Combination antiretroviral treatment for women previously treated only in pregnancy: week 24 results of AIDS clinical trials group protocol a5227. J Acquir Immune Defic Syndr 65:542-50
Haley, Danielle F; Golin, Carol; El-Sadr, Wafaa et al. (2014) Venue-based recruitment of women at elevated risk for HIV: an HIV Prevention Trials Network study. J Womens Health (Larchmt) 23:541-51

Showing the most recent 10 out of 27 publications