Weill Medical College of Cornell University

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HIV/AIDS:

Observational Studies. Glesby, Gulick, Jacobs, Marks, Merrick, Siegel, Singh, Vaamonde, Vogler, Wilkin. The Center for Special Studies (HIV clinic) at New York-Presbyterian-Weill Cornell 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, and hepatic steatosis. 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) through ongoing collaboration. Fellows have the opportunity to design, conduct, and analyze studies using the databases.

• Marks KM, Clarke RM, Bussel JB, Talal AH, Glesby MJ. Risk factors for thrombocytopenia in the era of potent antiretroviral therapy. JAIDS 2009;52:595-99.
• Tien PC, Schneider MF, Cox C, Cohen M, Karim R, Lazar J, Young M, Glesby MJ. HIV, highly active antiretroviral therapy and lipoprotein particle concentrations in the Women's Interagency HIV Study. AIDS 2010;24:2809-17.
• 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. Glesby, Gulick, Marks, Vogler, Wilkin. The Cornell HIV/AIDSClinical 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 three NIH-funded networks: the AIDS Clinical Trials Group (ACTG), the HIV Prevention Network (HPTN), and the NIH-funded AIDS Malignancy Consortium (AMC). Other studies are sponsored by Objectif Recherche VaCcin SIDA (ORVACS, a French non-profit organization) and the pharmaceutical industry. Current clinical investigation centers on three broad areas: (1) antiretroviral agents for treatment and prevention; (2) immune-based therapies; and (3) 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 (ACTG study A5257); HIV therapy for treatment-experienced patients (ACTG A5241); evaluation of adherence interventions (ACTG A5251); studies of investigational antiretroviral drugs (dolutegravir; tenofovir pro-drug); novel pre-exposure prophylaxis (PrEP) regimens (HPTN 069/ACTG 5303); approaches to reduce the immune activation thought to contribute to HIV complications (ACTG A5258; A5275); antiretroviral intensification and therapeutic vaccination to reduce the viral reservoir (Eramune 002); treatment of HPV-associated anal dysplasia (AMC 076); prevention of HIV-related complications (HPV vaccine in ACTG A5298); safety, efficacy, and pharmacokinetics of boceprevir in HCV/HIV co-infection; novel diagnostic method for tuberculosis (ACTG A5295). There are opportunities for fellows to participate in all aspects of HIV/AIDS clinical trials. Fellows may spend their fellowship research year(s) 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 (Masters Degree Program in Clinical Investigation).