HPV Clinical Trials
HPV is the most common sexually transmitted disease and is associated with premalignant lesions of the cervix and anus (squamous intraepithelial lesions or SIL). Anal carcinoma is increased among HIV-infected people. Our prior work has assessed the safety, immunogenicity, and efficacy of the quadrivalent HPV vaccine in people living with HIV. Other clinical trials are assessing the efficacy of ablative and topical therapies for the treatment anal cancer precursors. The ANCHOR study is an NCI-sponsored clinical trial assessing whether 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. Wilkin has completed a multisite, randomized clinical trial investigating a novel HPV test-and-treat strategy with immediate cryotherapy for those women detected with HPV. Dr. 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. Future 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. Ellsworth is investigating novel HPV tests for cervical cancer and anal cancer precursors.
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 May 26;6:11-14.
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.
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.
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.
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.