This proposal for a K24 award (competing renewal) is to support the candidate, Roy M. Gulick, MD, MPH, Professor of Medicine and Director of the Cornell HIV Clinical Trials Unit, as an HIV/AIDS clinical researcher, leader, and mentor. Dr. Gulick has conducted clinical trials in HIV-infected patients since 1989, with a focus on antiretroviral studies. His long-term career goals are to develop and lead high-quality research to address clinically important questions in the treatment of patients with HIV/AIDS and to teach and mentor trainees to help develop their careers as clinical investigators.
The specific aims of the proposal are: (1) to compare two initial antiretroviral regimens in treatment-na?ve patients with HIV infection: zidovudine/lamivudine/abacavir plus tenofovir (a quadruple-nucleoside regimen) vs. a standard regimen of 2 nucleoside analogues plus efavirenz (2) to determine CD4 cell count changes and immune responses with the new CCR5 antagonist, maraviroc in subjects on antiretroviral therapy with suboptimal CD4 cell responses despite sustained virologic suppression (3) to mentor medical students, internal medicine residents, infectious disease fellows, and junior faculty at Weill Medical College of Cornell University as well as to train and mentor developing investigators in Haiti and to assist in the planning, design and conduct of antiretroviral studies in Haiti The specific aims will be accomplished by designing, conducting, and analyzing clinical trials of antiretroviral therapies, playing a leadership role in the NIH-funded AIDS Clinical Trials Group (ACTG) as Principal Investigator of the Cornell unit and as Chairman of the Optimization of Antiretroviral Therapy Committee, and by teaching and mentoring trainees from Weill Medical College of Cornell University and Haiti. Clinical trials of novel strategies and agents will improve the treatment of HIV-infected patients, both in the United States and the developing world. Effective training and mentoring will help develop future clinical investigators both in the United States and in developing countries, such as Haiti.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
5K24AI051966-09
Application #
8054803
Study Section
Acquired Immunodeficiency Syndrome Research Review Committee (AIDS)
Program Officer
Livnat, Daniella
Project Start
2002-04-01
Project End
2013-04-30
Budget Start
2011-05-01
Budget End
2012-04-30
Support Year
9
Fiscal Year
2011
Total Cost
$183,986
Indirect Cost
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
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
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
Sax, Paul E; Sypek, Alexis; Berkowitz, Bethany K et al. (2014) HIV cure strategies: how good must they be to improve on current antiretroviral therapy? PLoS One 9:e113031
Haas, David W; Severe, Patrice; Jean Juste, Marc Antoine et al. (2014) Functional CYP2B6 variants and virologic response to an efavirenz-containing regimen in Port-au-Prince, Haiti. J Antimicrob Chemother 69:2187-90
Gulick, Roy M; Fatkenheuer, Gerd; Burnside, Robert et al. (2014) Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr 65:78-81
Johnson, Brent A; Ribaudo, Heather; Gulick, Roy M et al. (2013) Modeling clinical endpoints as a function of time of switch to second-line ART with incomplete data on switching times. Biometrics 69:732-40
Zhang, Xinyan; Tierney, Camlin; Albrecht, Mary et al. (2013) Discordant associations between SLCO1B1 521T?C and plasma levels of ritonavir-boosted protease inhibitors in AIDS clinical trials group study A5146. Ther Drug Monit 35:209-16
Ribaudo, Heather J; Smith, Kimberly Y; Robbins, Gregory K et al. (2013) Racial differences in response to antiretroviral therapy for HIV infection: an AIDS clinical trials group (ACTG) study analysis. Clin Infect Dis 57:1607-17
Bedoya, Felipe; Cheng, Guang-Shing; Leibow, Abigail et al. (2013) Viral antigen induces differentiation of Foxp3+ natural regulatory T cells in influenza virus-infected mice. J Immunol 190:6115-25
Wilkin, Timothy J; Lalama, Christina M; McKinnon, John et al. (2012) A pilot trial of adding maraviroc to suppressive antiretroviral therapy for suboptimal CD4? T-cell recovery despite sustained virologic suppression: ACTG A5256. J Infect Dis 206:534-42

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