Abstract

This proposal is to support the candidate, Roy M. Gulick, MD, MPH, Associate Professor of Medicine and the Director of the Cornell HIV Clinical Tdals Unit, as an HIV/AIDS clinical researcher. Dr+ Gulick has conducted clinical trials in H IV-infected patients since 1989, with a focus on antiretroviral therapy studies. His long-term career goals are to design, conduct, and analyze 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 three simple protease inhibitor (PI)-spadng regimens in HIV-infected, treatment-naTve patients: zidovudine/lamivudine with either (a) the non-nucleoside reverse transcriptase inhibitor (NNRTI), efavirenz; (b) the nucleoside reverse transcriptase inhibitor (nRTI), abacavir; or (c) the combination of efavirenz and abacavir; (2) (a) to evaluate and compare the safety, pharmacokinetics, and antiretroviral activity of four dose levels of T-1249, an investigational HIV fusion inhibitor; and (b) to design and implement a pilot study of dual HIV entry inhibitors; (3): to study an HIV gag DNA vaccine in HIV-infected patients with CD4 cell counts >500/mm3 and virologic suppression on a potent antiretroviral regimen; and (4): to assist in the planning, design and conduct of antiretroviral therapy studies in Haiti.
The specific aims will be accomplished by designing, conducting, and analyzing clinical tdals of both antiretroviral therapies and immune-based therapies, and by teaching and mentoring trainees from Weill Medical College of Cornell University and developing a training program for prospective investigators from developing countries, such as Haiti. Clinical trials of novel drugs and strategies will improve the treatment of HIV-infected patients, both in the United States and the developing world. Effective mentodng and training will help develop future clinical investigators.

  Funding Agency

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 #
5K24AI051966-05
Application #
7173813
Study Section
Acquired Immunodeficiency Syndrome Research Review Committee (AIDS)
Program Officer
Livnat, Daniella
Project Start
2003-02-01
Project End
2008-01-31
Budget Start
2007-02-01
Budget End
2008-01-31
Support Year
5
Fiscal Year
2007
Total Cost
$140,514
Indirect Cost

  Institution

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

  Publications

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
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
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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