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. Ongoing studies are assessing the efficacy of the quadrivalent HPV vaccine in HIV-infected adults for prevention of anal and oral infections. 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 prevent 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 is chairing an ongoing international clinical trial investigating a promising alternative screening strategy, a novel HPV test-and-treat strategy with immediate cryotherapy for those women detected with HPV. Dr. Wilkin collaborates 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.
- Godfrey CC, Michelow PM, Godard M, Sahasrabuddhe VV, Darden J, Firnhaber CS, Wetherall NT, Bremer J, Coombs RW, Wilkin T; A5282 Study Team. Improving diagnostic capability for HPV disease internationally within the NIH-NIAID Division of AIDS Clinical Trial Networks. Am J Clin Pathol. 2013 Dec; 140(6):881-9.
- Stier EA, Goldstone SE, Einstein MH, Jay N, Berry JM, Wilkin T, Lee JY, Darragh TM, Costa MD, Panther L, Aboulafia D, Palefsky JM. Safety and efficacy of topical Cidofovir to treat high-grade perianal and vulvar intraepithelial neoplasia in HIV-positive men and women. AIDS. 2013 27(4):545-51.
- Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis. 2010 Oct 15;202:1246-53.
- Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia DM, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. High grade anal intraepithelial neoplasia among HIV-1-infected men screening for a multi-center clinical trial of a human papillomavirus vaccine. HIV Clinical Trials. 2013; 14(2):75-79.