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.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Midcareer Investigator Award in Patient-Oriented Research (K24)
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Acquired Immunodeficiency Syndrome Research Review Committee (AIDS)
Program Officer
Livnat, Daniella
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Weill Medical College of Cornell University
Internal Medicine/Medicine
Schools of Medicine
New York
United States
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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
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
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
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
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
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
Putcharoen, Opass; Lee, Sun Hee; Henrich, Timothy J et al. (2012) HIV-1 clinical isolates resistant to CCR5 antagonists exhibit delayed entry kinetics that are corrected in the presence of drug. J Virol 86:1119-28

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