Human Papillomavirus (HPV)

HPV Clinical Trials

Ellsworth

HPV is the most common sexually transmitted infection and is associated with premalignant lesions of the cervix and anus (squamous intraepithelial lesions or SIL) and causes nearly all anal, oropharyngeal, and cervical cancer. HPV-related cancer occurs more frequently in persons with HIV. Our prior work has assessed the safety, immunogenicity, and efficacy of the quadrivalent HPV vaccine in people living with HIV. We have conducted clinical trials toassess the efficacy of ablative and topical therapies for the treatment anal cancer precursors. The ANCHOR study was an NCI-sponsored clinical trial that has shown treatment of anal cancer precursors prevents invasive anal cancer.  We are leading HPV-related cancer screening and prevention studies in Latin American and Puerto Rico as well as sub-Saharan Africa.

Dr. Grant Ellsworth, under the ongoing mentorship of Dr. Timothy Wilkin continues to conduct and develop clinical research to prevent and screen for anal and cervical cancer.  He has assumed the role of contact-PI for a collaborative NCI—funding group exploring novel ways to screen for and prevent oropharyngeal cancer, cervical cancer, and anal cancer among person with HIV in the Carribean and Latin America. His focus is on improved screening for precancerous lesions as well as the use of novel biomarkers to better predict one’s cancer risk once diagnosed with precancerous lesions.Pinto LA, Wilkin TJ, Kemp TJ, Abrahamsen M, Isaacs-Soriano K, Pan Y, Webster-Cyriaque J, Palefsky JM, Giuliano AR. Oral and systemic HPV antibody kinetics post-vaccination among HIV-positive and HIV-negative men. Vaccine. 2019 Apr 24;37(18):2502-2510. doi: 10.1016/j.vaccine.2019.03.034. Epub 2019 Mar 30. PMID: 30940485; PMCID: PMC6863043.

Goldstone SE, Lensing SY, Stier EA, Darragh T, Lee JY, van Zante A, Jay N, Berry-Lawhorn JM, Cranston RD, Mitsuyasu R, Aboulafia D, Palefsky JM, Wilkin T. A Randomized Clinical Trial of Infrared Coagulation Ablation Versus Active Monitoring of Intra-anal High-grade Dysplasia in Adults With Human Immunodeficiency Virus Infection: An AIDS Malignancy Consortium Trial. Clin Infect Dis. 2019 Mar 19;68(7):1204-1212. doi: 10.1093/cid/ciy615. PMID: 30060087; PMCID: PMC6588032.

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 Oct 15;67(9):1339-1346. doi: 10.1093/cid/ciy274. PMID: 29659751; PMCID: PMC6186857.

Cranston RD, Cespedes MS, Paczuski P, Yang M, Coombs RW, Dragavon J, Saah A, Godfrey C, Webster-Cyriaque JY, Chiao EY, Bastow B, Wilkin T; ACTG 5298 Study Team. High Baseline Anal Human Papillomavirus and Abnormal Anal Cytology in a Phase 3 Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Individuals Older Than 26 Years: ACTG 5298. Sex Transm Dis. 2018 Apr;45(4):266-271 doi: 10.1097/OLQ.0000000000000745. PMID: 29528986; PMCID: PMC5868482.

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. 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. PubMed PMID: 34110312.

Firnhaber C, Swarts A, Jezile V, Mulongo M, Goeieman B, Williams S, Faesen M, Michelow P, Wilkin T. Human Papillomavirus Vaccination Prior to Loop Electroexcision Procedure Does Not Prevent Recurrent Cervical High-grade Squamous Intraepithelial Lesions in Women Living With Human Immunodeficiency Virus: A Randomized, Double-blind, Placebo-controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):e2211-e2216. doi: 10.1093/cid/ciaa1456. PMID: 32975556; PMCID: PMC9630863.

Palefsky JM, Lee JY, Jay N, Goldstone SE, Darragh TM, Dunlevy HA, Rosa-Cunha I, Arons A, Pugliese JC, Vena D, Sparano JA, Wilkin TJ, Bucher G, Stier EA, Tirado Gomez M, Flowers L, Barroso LF, Mitsuyasu RT, Lensing SY, Logan J, Aboulafia DM, Schouten JT, de la Ossa J, Levine R, Korman JD, Hagensee M, Atkinson TM, Einstein MH, Cracchiolo BM, Wiley D, Ellsworth GB, Brickman C, Berry-Lawhorn JM. Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer. N Engl J Med. 2022 Jun 16;386(24):2273-2282. 10.1056/NEJMoa2201048. PubMed PMID: 35704479; PubMed Central PMCID: PMC9717677.

Ellsworth G, Shen R, Marcelin KA, Majumdar R, Bazil M, Moore G, Nelson M, Alland I, Sepulveda G, Wilkin T, Higginson DS. High Specificity of HPV Cell-Free DNA Tests in Persons With HIV for the Detection of HPV-Related Cancer. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):73-81. doi: 10.1097/QAI.0000000000003231. PubMed PMID: 37276242; PubMed Central PMCID: PMC10500630.

Grants

AMC Domestic Site (UM1 CA121947)

ULACNet ROCCHA Consortium (U54 CA242639)