drugset / Trial / NCT00941889
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.
Timeline
- Start
- 2007-07
- Primary completion
- 2011-07
- Completion
- 2011-07
Publications
- Background StatBite: Prevalence of HPV in a cohort of U.S. men. J Natl Cancer Inst. 2009 Feb 18;101(4):223. doi: 10.1093/jnci/djp008. Epub 2009 Feb 10. No abstract available.
- Background Human papillomavirus vaccines. WHO position paper. Wkly Epidemiol Rec. 2009 Apr 10;84(15):118-31. No abstract available. English, French.
- Background Chitale R. Merck hopes to extend gardasil vaccine to men. J Natl Cancer Inst. 2009 Feb 18;101(4):222-3. doi: 10.1093/jnci/djp014. Epub 2009 Feb 10. No abstract available.
- Background Gillespie MB, Smith J, Gibbs K, McRackan T, Rubinchik S, Day TA, Sutkowski N. Human papillomavirus and head and neck cancer: a growing concern. J S C Med Assoc. 2008 Dec;104(8):247-51.
- Background Stanley M. The epidemiology and burden of HPV disease. Nurs Times. 2008 Sep 9-15;104(36):38-40.
- Background Gross G. Impact of prophylactic human papillomavirus vaccines on dermatology and venereology. G Ital Dermatol Venereol. 2008 Aug;143(4):259-65.
- Background Herbert J, Coffin J. Reducing patient risk for human papillomavirus infection and cervical cancer. J Am Osteopath Assoc. 2008 Feb;108(2):65-70.
- Background Dowling TS. Mandating a human papillomavirus vaccine: an investigation into whether such legislation is constitutional and prudent. Am J Law Med. 2008;34(1):65-84. doi: 10.1177/009885880803400103. No abstract available.
- Background Dunne EF, Markowitz LE. Genital human papillomavirus infection. Clin Infect Dis. 2006 Sep 1;43(5):624-9. doi: 10.1086/505982. Epub 2006 Jul 26.
- Background Winer RL, Lee SK, Hughes JP, Adam DE, Kiviat NB, Koutsky LA. Genital human papillomavirus infection: incidence and risk factors in a cohort of female university students. Am J Epidemiol. 2003 Feb 1;157(3):218-26. doi: 10.1093/aje/kwf180.
- Background Vukasin P. Anal condyloma and HIV-associated anal disease. Surg Clin North Am. 2002 Dec;82(6):1199-211, vi. doi: 10.1016/s0039-6109(02)00085-3.
- Background Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8. doi: 10.1016/S1470-2045(05)70101-7.
- Background Reisinger KS, Block SL, Lazcano E, et al. A randomized controlled trial to evaluate the safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in preadolescents and adolescents. The 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3-5
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gardasil | Vaccine | 0.5 ml | Intramuscular |