Observational Studies

Evering, 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 persons living with HIV (PLWH) dating back to 1991 are available. Completed projects include case-control studies of osteonecrosis, diabetes mellitus, and polycythemia in PLWH; 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 PLWH (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.

Yu EA, Alemán JO, Hoover DR, Shi Q, Verano M, Anastos K, Tien PC, Sharma A, Kardashian A, Cohen MH, Golub ET, Michel KG, Gustafson DR, Glesby MJ. Plasma metabolomic analysis indicates flavonoids and sorbic acid are associated with incident diabetes: A nested case-control study among Women's Interagency HIV Study participants. PLoS One. 2022 Jul 8;17(7):e0271207.

Gogokhia L, Taur Y, Juluru K, Yagan N, Zhu YS, Pamer E, Glesby MJ. Intestinal Dysbiosis and Markers of Systemic Inflammation in Viscerally and Generally Obese Persons Living With HIV. J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):81-89.

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


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 NCI-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 women’s health. Current specific projects include novel interventions to reduce the size of the HIV reservoir (A5386); 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, AMC 103, ANCHOR); novel HBV immunization strategies (ACTG A5379);novel treatment strategy for HBV/HIV (A5394); management of weight gain on HIV therapy (A5391); CMV treatment to dampen inflammation (A5383) ; primary prevention of cardiovascular disease (REPRIEVE study; A5415).

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).

Hsu J, Van Besien K, Glesby MJ, Pahwa S, Coletti A, Warshaw MG, Petz L, Moore TB, Chen YH, Pallikkuth S, Dhummakupt A, Cortado R, Golner A, Bone F, Baldo M, Riches M, Mellors JW, Tobin NH, Browning R, Persaud D, Bryson Y; International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1107 Team. HIV-1 remission and possible cure in a woman after haplo-cord blood transplant. Cell. 2023 Mar 16;186(6):1115-1126.

Ellsworth GB, Burke LA, Wells MT, Mishra S, Caffrey M, Liddle D, Madhava M, O'Neal C, Anderson PL, Bushman L, Ellison L, Stein J, Gulick RM. Randomized Pilot Study of an Advanced Smart-Pill Bottle as an Adherence Intervention in Patients With HIV on Antiretroviral Treatment. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):73-80.

Ellsworth GB, Stier EA, Chiao EY, Lensing SY, Darragh T, Jay N, Berry-Lawhorn JM, Einstein M, Barroso LF, Cranston RD, Levine R, Guiot HM, French AL, Goldstone SE, Preiser W, Claassen M, Palefsky JM, Wilkin TJ; AIDS Malignancy Consortium. Xpert HPV as a Screening Tool for Anal Histologic High-Grade Squamous Intraepithelial Lesions in Women Living With HIV. J Acquir Immune Defic Syndr. 2021 Jul 1;87(3):978-984.

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

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.

Naggie S, Fierer DS, Hughes MD, Kim AY, Luetkemeyer A, Vu V, Roa J, Rwema S, Brainard DM, McHutchison JG, Peters MG, Kiser JJ, Marks KM, Chung RT; Acquired Immunodeficiency Syndrome Clinical Trials Group (ACTG) A5327 Study Team. Ledipasvir/Sofosbuvir for 8 Weeks to Treat Acute Hepatitis C Virus Infections in Men With Human Immunodeficiency Virus Infections: Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals. Clin Infect Dis. 2019 Jul 18;69(3):514-522.

MacBrayne CE, Marks KM, Fierer DS, Naggie S, Chung RT, Hughes MD, Kim AY, Peters MG, Brainard DM, Seifert SM, Castillo-Mancilla JR, Bushman LR, Anderson PL, Kiser JJ. Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate. J Antimicrob Chemother. 2018 Aug 1;73(8):2112-2119. doi: 10.1093/jac/dky146. PMID: 29746648; PMCID: PMC6054189.