Clinical trial NCT02615860 - References

Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients — Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients

Citation(s)

•   Berry JM, Jay N, Cranston RD, Darragh TM, Holly EA, Welton ML, Palefsky JM
  Progression of anal high-grade squamous intraepithelial lesions to invasive anal cancer among HIV-infected men who have sex with men. Int J Cancer. 2014 Mar 1;134(5):1147-55. doi: 10.1002/ijc.28431. Epub 2013 Sep 14.
•   de Pokomandy A, Rouleau D, Ghattas G, Trottier H, Vézina S, Coté P, Macleod J, Allaire G, Hadjeres R, Franco EL, Coutlée F
  HAART and progression to high-grade anal intraepithelial neoplasia in men who have sex with men and are infected with HIV. Clin Infect Dis. 2011 May;52(9):1174-81. doi: 10.1093/cid/cir064. Epub 2011 Mar 1.
•   Fox PA, Nathan M, Francis N, Singh N, Weir J, Dixon G, Barton SE, Bower M
  A double-blind, randomized controlled trial of the use of imiquimod cream for the treatment of anal canal high-grade anal intraepithelial neoplasia in HIV-positive MSM on HAART, with long-term follow-up data including the use of open-label imiquimod. AIDS. 2010 Sep 24;24(15):2331-5. doi: 10.1097/QAD.0b013e32833d466c.
•   Fox PA
  Treatment options for anal intraepithelial neoplasia and evidence for their effectiveness. Sex Health. 2012 Dec;9(6):587-92. doi: 10.1071/SH11157. Review.
•   Goldie SJ, Kuntz KM, Weinstein MC, Freedberg KA, Welton ML, Palefsky JM
  The clinical effectiveness and cost-effectiveness of screening for anal squamous intraepithelial lesions in homosexual and bisexual HIV-positive men. JAMA. 1999 May 19;281(19):1822-9.
•   Heitland W, Schädlich PK, Chen X, Rémy V, Moro L
  Annual cost of hospitalization, inpatient rehabilitation and sick leave of anal cancer in Germany. J Med Econ. 2013;16(3):364-71. doi: 10.3111/13696998.2012.759582. Epub 2013 Jan 2.
•   Hessol NA, Holly EA, Efird JT, Minkoff H, Weber KM, Darragh TM, Burk RD, Strickler HD, Greenblatt RM, Palefsky JM
  Concomitant anal and cervical human papillomavirusV infections and intraepithelial neoplasia in HIV-infected and uninfected women. AIDS. 2013 Jul 17;27(11):1743-51. doi: 10.1097/QAD.0b013e3283601b09.
•   Julious SA, Campbell MJ
  Tutorial in biostatistics: sample sizes for parallel group clinical trials with binary data. Stat Med. 2012 Oct 30;31(24):2904-36. doi: 10.1002/sim.5381. Epub 2012 Jun 19.
•   Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Stücker M, Altmeyer P, Swoboda J, Pfister H, Wieland U; German Competence Network HIV/AIDS
  Imiquimod leads to a decrease of human papillomavirus DNA and to a sustained clearance of anal intraepithelial neoplasia in HIV-infected men. J Invest Dermatol. 2008 Aug;128(8):2078-83. doi: 10.1038/jid.2008.24. Epub 2008 Feb 14.
•   Kreuter A, Potthoff A, Brockmeyer NH, Gambichler T, Swoboda J, Stücker M, Schmitt M, Pfister H, Wieland U; German Competence Network HIV/AIDS
  Anal carcinoma in human immunodeficiency virus-positive men: results of a prospective study from Germany. Br J Dermatol. 2010 Jun;162(6):1269-77. doi: 10.1111/j.1365-2133.2010.09712.x. Epub 2010 Feb 22.
•   Kreuter A, Wieland U
  Human papillomavirus-associated diseases in HIV-infected men who have sex with men. Curr Opin Infect Dis. 2009 Apr;22(2):109-14. doi: 10.1097/QCO.0b013e3283229fc8. Review.
•   Lam JM, Hoch JS, Tinmouth J, Sano M, Raboud J, Salit IE
  Cost-effectiveness of screening for anal precancers in HIV-positive men. AIDS. 2011 Mar 13;25(5):635-42. doi: 10.1097/QAD.0b013e3283434594.
•   Legarth R, Helleberg M, Kronborg G, Larsen CS, Pedersen G, Pedersen C, Jensen J, Nielsen LN, Gerstoft J, Obel N
  Anal carcinoma in HIV-infected patients in the period 1995-2009: a Danish nationwide cohort study. Scand J Infect Dis. 2013 Jun;45(6):453-9. doi: 10.3109/00365548.2012.737476. Epub 2013 Jan 7.
•   Macaya A, Muñoz-Santos C, Balaguer A, Barberà MJ
  Interventions for anal canal intraepithelial neoplasia. Cochrane Database Syst Rev. 2012 Dec 12;12:CD009244. doi: 10.1002/14651858.CD009244.pub2. Review.
•   Machalek DA, Poynten M, Jin F, Fairley CK, Farnsworth A, Garland SM, Hillman RJ, Petoumenos K, Roberts J, Tabrizi SN, Templeton DJ, Grulich AE
  Anal human papillomavirus infection and associated neoplastic lesions in men who have sex with men: a systematic review and meta-analysis. Lancet Oncol. 2012 May;13(5):487-500. doi: 10.1016/S1470-2045(12)70080-3. Epub 2012 Mar 23. Review.
•   Orchard M, Roman A, Parvaiz AC
  Anal intraepithelial neoplasia--is treatment better than observation? Int J Surg. 2013;11(6):438-41. doi: 10.1016/j.ijsu.2013.04.011. Epub 2013 May 2. Review.
•   Palefsky JM, Holly EA, Efirdc JT, Da Costa M, Jay N, Berry JM, Darragh TM
  Anal intraepithelial neoplasia in the highly active antiretroviral therapy era among HIV-positive men who have sex with men. AIDS. 2005 Sep 2;19(13):1407-14.
•   Palefsky JM
  Anal cancer prevention in HIV-positive men and women. Curr Opin Oncol. 2009 Sep;21(5):433-8. doi: 10.1097/CCO.0b013e32832f511a. Review.
•   Piketty C, Selinger-Leneman H, Bouvier AM, Belot A, Mary-Krause M, Duvivier C, Bonmarchand M, Abramowitz L, Costagliola D, Grabar S
  Incidence of HIV-related anal cancer remains increased despite long-term combined antiretroviral treatment: results from the french hospital database on HIV. J Clin Oncol. 2012 Dec 10;30(35):4360-6. doi: 10.1200/JCO.2012.44.5486. Epub 2012 Oct 22.
•   Richel O, de Vries HJ, van Noesel CJ, Dijkgraaf MG, Prins JM
  Comparison of imiquimod, topical fluorouracil, and electrocautery for the treatment of anal intraepithelial neoplasia in HIV-positive men who have sex with men: an open-label, randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):346-53. doi: 10.1016/S1470-2045(13)70067-6. Epub 2013 Mar 15.
•   Richel O, Wieland U, de Vries HJ, Brockmeyer NH, van Noesel C, Potthoff A, Prins JM, Kreuter A
  Topical 5-fluorouracil treatment of anal intraepithelial neoplasia in human immunodeficiency virus-positive men. Br J Dermatol. 2010 Dec;163(6):1301-7. doi: 10.1111/j.1365-2133.2010.09982.x. Epub 2010 Nov 4.
•   Sanclemente G, Herrera S, Tyring SK, Rady PL, Zuleta JJ, Correa LA, He Q, Wolff JC
  Human papillomavirus (HPV) viral load and HPV type in the clinical outcome of HIV-positive patients treated with imiquimod for anogenital warts and anal intraepithelial neoplasia. J Eur Acad Dermatol Venereol. 2007 Sep;21(8):1054-60.
•   Silling S, Kreuter A, Hellmich M, Swoboda J, Pfister H, Wieland U
  Human papillomavirus oncogene mRNA testing for the detection of anal dysplasia in HIV-positive men who have sex with men. J Clin Virol. 2012 Apr;53(4):325-31. doi: 10.1016/j.jcv.2011.12.029. Epub 2012 Jan 18.
•   Silverberg MJ, Lau B, Justice AC, Engels E, Gill MJ, Goedert JJ, Kirk GD, D'Souza G, Bosch RJ, Brooks JT, Napravnik S, Hessol NA, Jacobson LP, Kitahata MM, Klein MB, Moore RD, Rodriguez B, Rourke SB, Saag MS, Sterling TR, Gebo KA, Press N, Martin JN, Dubrow R; North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) of IeDEA
  Risk of anal cancer in HIV-infected and HIV-uninfected individuals in North America. Clin Infect Dis. 2012 Apr;54(7):1026-34. doi: 10.1093/cid/cir1012. Epub 2012 Jan 30.
•   Singh JC, Kuohung V, Palefsky JM
  Efficacy of trichloroacetic acid in the treatment of anal intraepithelial neoplasia in HIV-positive and HIV-negative men who have sex with men. J Acquir Immune Defic Syndr. 2009 Dec 1;52(4):474-9. doi: 10.1097/QAI.0b013e3181bc0f10. Erratum in: J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):e105-6.
•   Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N; Forum Group Members; Bethesda 2001 Workshop
  The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9. Review.
•   Steele SR, Varma MG, Melton GB, Ross HM, Rafferty JF, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons
  Practice parameters for anal squamous neoplasms. Dis Colon Rectum. 2012 Jul;55(7):735-49. doi: 10.1097/DCR.0b013e318255815e.
•   van der Zee RP, Richel O, de Vries HJ, Prins JM
  The increasing incidence of anal cancer: can it be explained by trends in risk groups? Neth J Med. 2013 Oct;71(8):401-11. Review.
•   Vogel M, Friedrich O, Lüchters G, Holleczek B, Wasmuth JC, Anadol E, Schwarze-Zander C, Nattermann J, Oldenburg J, Sauerbruch T, Rockstroh JK, Spengler U
  Cancer risk in HIV-infected individuals on HAART is largely attributed to oncogenic infections and state of immunocompetence. Eur J Med Res. 2011 Mar 28;16(3):101-7.
•   Wieland U, Kreuter A
  One step towards standardised management of anal dysplasia. Lancet Oncol. 2013 Apr;14(4):273-4. doi: 10.1016/S1470-2045(13)70099-8. Epub 2013 Mar 15.

Efficacy and Safety of Topical Trichloroacetic Acid vs. Electrocautery for the Treatment of Anal Intraepithelial Neoplasia in HIV-positive Patients (TECAIN) - a Randomized Controlled Trial

Details for clinical trial NCT02615860