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Observational Studies

Glesby, Gulick, Jacobs, Johnston, Kapadia, Marks, Merrick, Siegler, Singh, Vaamonde, Vogler, Wilkin

The Center for Special Studies (HIV clinic) at NewYork-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; clinical use of the HIV tropism assay; and an archived genotypic resistance test. Ongoing studies are focusing on aging-related issues in people living with HIV (in collaboration with Dr. Eugenia Siegler, Division of Geriatrics and Palliative Medicine). Other projects utilize data from the Multicenter AIDS Cohort Study-Women’s Interagency HIV Study Combined Cohort Study (a cohort study of men and women with or at risk for HIV infection). Fellows have the opportunity to design, conduct, and analyze studies using the databases.

Johnston CD, Hoover DR, Shi Q, Sharma A, Hanna DB, Anastos K, Tien PC, Fischl M, Gustafson D, Spence A, Karim R, French A Schneider M, Adimora A, Moran C, Konkle-Parker D, Glesby MJ. White blood cell counts, lymphocyte subsets, and incident diabetes mellitus in women living with and without HIV. AIDS Res Hum Retro 2020; 36:131-133.

Johnston CD, Ifeagwu K-CC, Siegler EL, Derry H, Burchett CO, Rice MC, Gupta SK, Choi ME, Glesby MJ. Elevated cardiac risk score by Atherosclerotic Cardiovascular Disease calculation is associated with albuminuria in older people living with HIV. AIDS 2020; 34:947-49.

Glesby MJ, Hanna DB, Hoover DR, Shi Q, Yin MT, Kaplan R, Tien PC, Cohen M, Kathryn A, Anjali A. Abdominal fat depots, insulin resistance and incident diabetes mellitus in women with and without HIV infection. AIDS 2018; 2018;32:1643-1650

Kapadia SN, Singh HK, Jones S, Merrick S, Vaamonde CM. Missed Opportunities for HIV Testing of Patients Tested for Sexually Transmitted Infections at a Large Urban Health Care System From 2010 to 2015. Open Forum Infect Dis. 2018 Jul 19;5(7):ofy165.

Clinical Trials of HIV/AIDS

Caskey, Ellsworth, Glesby, Gulick, Kapadia, Marks, Schackman, Vogler, Wilkin


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 pharmaceutical industry. Current clinical investigation centers on three broad areas:

  1. antiretroviral agents and strategies for treatment and prevention;
  2. treatment and prevention of HIV-related complications, including co-infections, anal dysplasia/cancer, and complications of antiretroviral therapy; and
  3. early studies of HIV cure.

Additional areas of investigation are pharmacokinetics of HIV drugs and HIV-infected women’s health. Current specific projects include initiation of antiretroviral therapy in acute HIV (ACTG A5354); long-acting injectable antiretrovirals or novel monoclonal antibodies (ACTG A5357, A5359, A5377); observational study of HIV reservoirs (ACTG 5321); novel pre-exposure prophylaxis (PrEP) regimens (HPTN 083); treatment of HPV-associated anal dysplasia (AMC 088, ANCHOR); novel HBV immunization strategies (ACTG A5379); observational study of aging in HIV (ACTG A5322); primary prevention of cardiovascular disease (REPRIEVE study); antiretroviral intensification for HIV-associated Neurocognitive Dysfunction (ACTG 5324).

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).

Kotler DP, He Q, Engelson ES, Albu JB, Glesby MJ. The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial. Antivir Ther. 2016; 21:107-16.

Sereti I, Gulick RM, Krishnan S, Migueles SA, Palfreeman A, Touzeau-Römer V, Belloso WH, Emery S, Law MG; INSIGHT START Study Group. ART in HIV-Positive Persons With Low Pretreatment Viremia: Results From the START Trial. J Acquir Immune Defic Syndr. 2019; 81:456-462.

Gulick RM, Wilkin TJ, Chen YQ, Landovitz RJ, Amico KR, Young AM, Richardson P, Marzinke MA, Hendrix CW, Eshleman SH, McGowan I, Cottle LM, Andrade A, Marcus C, Klingman KL, Chege W, Rinehart AR, Rooney JF, Andrew P, Salata RA, Magnus M, Farley JE, Liu A, Frank I, Ho K, Santana J, Stekler JD, McCauley M, Mayer KH. Phase 2 Study of the Safety and Tolerability of Maraviroc-containing regimens to prevent HIV infection in Men who have Sex with Men (HPTN069/ACTG A5305). J Infect Dis 2017; 215:238-246

Ellsworth GB, Lensing SY, Ogilvie CB, Lee JY, Goldstone SE, Berry-Lawhorn JM, Jay N, Stier EA, Logan JS, Einstein MH, Saah A, Mitsuyasu RT, Aboulafia D, Palefsky JM, Wilkin TJ. A delayed dose of quadrivalent human papillomavirus vaccine demonstrates immune memory in HIV-1-infected men. Papillomavirus Res. 2018; 6:11-14.

Kapadia SN, Wu C, Mayer KH, Wilkin TJ, Amico KR, Landovitz RJ, Andrade A, Chen YQ, Chege W, McCauley M, Gulick RM, Schackman BR. No change in health-related quality of life for at-risk U.S. women and men starting HIV pre-exposure prophylaxis (PrEP): Findings from HPTN 069/ACTG A5305. PLoS One. 2018; 13(12):e0206577

Vogler MA, Smeaton LM, Wright RL, Cardoso SW, Sanchez J, Infante R, Moran LE, Godfrey C, Demeter LM, Johnson VA. Combination antiretroviral treatment for women previously treated only in pregnancy: week 24 results of AIDS clinical trials group protocol a5227. J Acquir Immune Defic Syndr. 2014; 65:542-50.

Wilkin TJ, Chen H, Cespedes MS, Leon-Cruz JT, Godfrey C, Chiao EY, Bastow B, Webster-Cyriaque J, Feng Q, Dragavon J, Coombs RW, Presti RM, Saah A, Cranston RD. A Randomized, Placebo-Controlled Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Adults Aged 27 Years or Older: AIDS Clinical Trials Group Protocol A5298. Clin Infect Dis. 2018; 67:1339-1346.

Borges ÁH, Neuhaus J, Babiker AG, Henry K, Jain MK, Palfreeman A, Mugyenyi P, Domingo P, Hoffmann C, Read TR, Pujari S, Meulbroek M, Johnson M, Wilkin T, Mitsuyasu R. Immediate Antiretroviral Therapy Reduces Risk of Infection-Related Cancer During Early HIV Infection. Clin Infect Dis. 2016 ;63:1668-1676.

Tashima KT, Smeaton LM, Fichtenbaum CJ, Andrade A, Eron JJ, Gandhi RT, Johnson VA, Klingman KL, Ritz J, Hodder S, Santana JL, Wilkin T, Haubrich RH; A5241 Study Team. HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial. Ann Intern Med. 2015; 163 :908-917.