HPV Clinical Trials
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 the majority of 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. Other clinical trials have assessed the efficacy of ablative and topical therapies for the treatment anal cancer precursors. The ANCHOR study is an NCI-sponsored clinical trial that has shown treatment of anal cancer precursors prevents invasive anal cancer. Cervical cancer is a major cause of morbidity and mortality in areas of the world without access to cervical cancer screening.
Dr. Timothy Wilkin has collaborated with South African investigators on studies of the novel point-of-care diagnostics for HPV infection, and a clinical trial investigating the role of HPV vaccination as an adjunct to treatment of cervical cancer precursors in sub-Saharan Africa. Current trials include trials of the 9-valent HPV vaccine to prevent oropharyngeal cancer and novel treatments for cervical cancer precursors in people living with HIV. Dr. Wilkin is a Principal Investigator on two National Cancer Institute funded collaborations that aim to improve HPV-related cancer screening and prevention in persons with HIV living in sub-Saharan African and Latin America and the Carribean. Dr. Ellsworth is investigating novel optimized HPV teststo detect cervical cancer and anal cancer precursors.
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.