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Observational Studies

Abraham, Glesby, Gulick, Jacobs, Marks, Merrick, Siegel, Singh, Vaamonde, Vogler, Wilkin

The Center for Special Studies (HIV clinic) at New York-Presbyterian/Weill Cornell Medical Center uses an electronic medical records system that is an invaluable resource for clinical research. Over 10,000 records of HIV-infected patients dating back to 1991 are available. Completed projects include case-control studies of osteonecrosis, diabetes mellitus, and polycythemia in HIV-infected patients, a retrospective review of the safety and efficacy of antiretroviral regimens containing three protease inhibitors, temporal trends in hospital admission diagnoses, hepatic steatosis, and clinical use of the HIV tropism assay. Ongoing studies are focusing on MMR vaccination and anal cancer screening in HIV-infected women. Other projects utilize data from the Women's Interagency HIV Study (WIHS, a cohort study of women with or at high risk for HIV infection) and the New York City Department of Health to investigate HIV-related outcomes and racial disparities in health care through ongoing collaboration. Fellows have the opportunity to design, conduct and analyze studies using the databases.

  • McCarthy MW, Genzen JR, Wilkin TJ, Singh HK. Use of a commercial HIV co-receptor tropism assay in clinical practice. AIDS Patient Care STDS. 2015; 29:53-4.
  • Shirley DK, Kaner RJ, Glesby MJ. Screening for chronic obstructive pulmonary disease (COPD) in an urban HIV clinic: a pilot study. AIDS Patient Care STDS. 2015; 29:232-9.
  • Singh HK, Chiu YL, Wilkin T. Measles, Mumps, and Rubella Serostatus and Response to MMR Vaccination Among HIV-Infected Adults. AIDS Patient Care STDS 2015 (epub).
  • Tien PC, Schneider, MF, Cox C, Karim R, Cohen M, Sharma A, Young M,Glesby MJ. Association of HIV infection with incident diabetes mellitus: impact of using hemoglobin A1C as a criterion for diabetes. J Acquir Immune Defic Syndr. 2012; 61:334-340.
  • Vorkas CK, Vaamonde CM, Glesby MJ. Testosterone replacement therapy and polycythemia in HIV-infected patients. AIDS. 2012; 26:243-45.

Clinical Trials of HIV/AIDS

Burke, Glesby, Gulick, Marks, Vogler, Wilkin


There are opportunities for fellows to participate in all aspects of HIV/AIDS clinical trials. Fellows may spend their fellowship research years conducting HIV/AIDS clinical research as part of the clinical trials unit under the mentorship of one of the HIV clinical trials investigators, and participate in the K30 program (Master's Degree Program in Clinical and Translational Investigation).The Cornell HIV/AIDS Clinical Trials Unit (CCTU) designs and conducts clinical trials in HIV-infected individuals and those at risk for HIV. The CCTU participates actively in studies sponsored by four NIH-funded networks: the AIDS Clinical Trials Group (ACTG), the HIV Prevention Network (HPTN), the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), and the NIH-funded AIDS Malignancy Consortium (AMC). Other studies are sponsored by the New York City Economic Development Corporation and the pharmaceutical industry. Current clinical investigation centers on two broad areas: (1) antiretroviral agents and strategies for treatment and prevention; and (2) treatment and prevention of HIV-related complications, including co-infections and complications of antiretroviral therapy. Additional areas of investigation are pharmacokinetics of HIV drugs and HIV-infected women's health. Current specific projects include studies of the initiation of antiretroviral therapy (INSIGHT START study); novel adherence interventions (investigator-initiated HABIT study); studies of investigational antiretroviral drugs and monoclonal antibodies (tenofovir pro-drug; CD4 attachment inhibitor; broadly neutralizing antibody 3BNC117); observational study of HIV reservoirs (ACTG 5321); proof-of-concept interventional studies to dampen inflammation and/or reduce HIV reservoir size (ACTG 5325, 5336, 5337); novel pre-exposure prophylaxis (PrEP) regimens (HPTN 069/ACTG 5305); treatment of HPV-associated anal dysplasia (AMC 076, 084, 088, ANCHOR); prevention of HIV-related complications (HPV vaccine in ACTG A5298); safety, efficacy, and pharmacokinetics of novel oral antiviral regimens in chronic and acute HCV/HIV co-infection (ACTG 5327, 5329); observational study of aging in HIV (ACTG 5322); CMV and immune activation (investigator-initiated study); and, doxycycline for COPD in HIV (NIH R34).

  • Caskey M, Klein F, Lorenzi JC, Seaman MS, West AP Jr, Buckley N, Kremer G, Nogueira L, Braunschweig M, Scheid JF, Horwitz JA, Shimeliovich I, Ben-Avraham S, Witmer-Pack M, Platten M, Lehmann C,Burke LA, Hawthorne T, Gorelick RJ, Walker BD, Keler T, Gulick RM, Fätkenheuer G, Schlesinger SJ, Nussenzweig MC. Viraemia suppressed in HIV-1-infected humans by broadly neutralizing antibody 3BNC117.Nature. 2015; 522:487-91.
  • Glesby MJ, Albu J, Chiu YL, Ham K, Engelson E, He Q, Muthukrishnan V, Ginsberg HN, Donovan D, Ernst J, Lesser M, Kotler DP. Recombinant human growth hormone and rosiglitazone for abdominal fat accumulation in HIV-infected patients with insulin resistance: a randomized, double-blind, placebo-controlled, factorial trial. PLoS One. 2013; 8(4):e61160.
  • Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. 5-year safety evaluation of maraviroc in HIV-1-infected, treatment-experienced patients. JAIDS 2014; 65:78-81.
  • Gulick RM, Ribaudo HJ, Smith KY, Robbins GK, Flexner C, Haubrich R, Chen Y, Fischl MA, Schackman BR, Riddler SA. Racial differences in response to antiretroviral therapy for HIV infection: an AIDS Clinical Trials Group (ACTG) study analysis. Clin Infect Dis 2013; 57:1607-1617.
  • Wilkin TJ, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia DM, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. High grade anal intraepithelial neoplasia among HIV-1-infected men screening for a multi-center clinical trial of a human papillomavirus vaccine. HIV Clinical Trials. 2013; 14(2):75-79.
  • Wilkin TJ, Lalama CM, McKinnon J, Gandhi RT, Lin N, Landay A, Ribaudo H, Fox L, Currier JS, Mellors JW, Gulick R, Tenorio AR. 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. 2012; 206-534-42.

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Infectious Diseases

Roy M. Gulick, M.D., Chief

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