The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata

HIV Infections Clinical Trial

Official title:

The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00941889
• Other study ID #: HRPO 07-0648
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 16, 2009
• Last updated: August 14, 2009
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: July 2009
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

A quadrivalent human papilloma virus (HPV) vaccine called Gardasil had recently (at start of study) been developed and approved by the FDA for the prevention of cervical HPV infection and cervical cancer, which is associated with infection from this virus. It is unknown whether the same vaccine could also be of benefit in treating anogenital warts, which are caused by the same virus. This is an important and clinically relevant question which needs to be answered. Anal warts have a high prevalence and recurrence and usually require extended lengths of treatment and follow-up, especially in the HIV population. At times, treatment of anal warts requires multiple surgeries to excise them if the burden of disease is high. Therefore, this disease represents a significant expense to patients and the health care system.

Further, the HPV virus that causes anal warts has been associated with anal cancer and with its preliminary lesion known as anal intraepithelial neoplasia (AIN). This study touches on two important, relevant and costly healthcare issues: finding a better treatment for the most common sexually transmitted disease in our country, and helping to prevent anal cancer, which is often a fatal disease.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age;

• HIV positive status;

• CD4 > 200 and viral RNA < 400 on anti-retroviral therapy (HAART) or CD4 > 350 if not on HARRT;

• the presence of anal warts that require surgical excision/ablation.

Exclusion Criteria:

• CD4 < 200 and/or viral RNA > 400 on HAART or CD4 < 350 and not on HAART ;

• low burden of anal warts that would not require surgical excision/ablation;

• previous vaccinations against HPV or allergic reactions to any vaccine component;

• patients who are currently pregnant;

• patients with a previous diagnosis of anal cancer;

• patients who are incarcerated;

• patients who have taken immunomodulators (i.e. interferon, interleukin, corticosteroids, etc.) within the last 90 days;

• patients who have had an opportunistic infection in the last 90 days or who have another intercurrent illness that precludes their safe enrollment in this study;

• patients who, in the judgment of the investigators, are unlikely to adhere to the protocol, either because of a substance abuse or psychiatric diagnosis, or other factors that would affect compliance;

• failure to strictly comply with the vaccination schedule.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Condylomata
• Anal Warts
• HIV Infections
• HIV Positive
• HIV Seropositivity

Intervention

Drug:
• Saline
0.5 ml
• Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.

Locations

Country	Name	City	State
United States	Washington University in St. Louis, Section of Colon Rectal Surgery	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

Dunne EF, Markowitz LE. Genital human papillomavirus infection. Clin Infect Dis. 2006 Sep 1;43(5):624-9. Epub 2006 Jul 26. Review. — View Citation

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. Review. — View Citation

Gross G. Impact of prophylactic human papillomavirus vaccines on dermatology and venereology. G Ital Dermatol Venereol. 2008 Aug;143(4):259-65. Review. — View Citation

Herbert J, Coffin J. Reducing patient risk for human papillomavirus infection and cervical cancer. J Am Osteopath Assoc. 2008 Feb;108(2):65-70. Review. — View Citation

Human papillomavirus vaccines. WHO position paper. Wkly Epidemiol Rec. 2009 Apr 10;84(15):118-31. English, French. — View Citation

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

Stanley M. The epidemiology and burden of HPV disease. Nurs Times. 2008 Sep 9-15;104(36):38-40. — View Citation

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. — View Citation

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. — View Citation

Vukasin P. Anal condyloma and HIV-associated anal disease. Surg Clin North Am. 2002 Dec;82(6):1199-211, vi. Review. — View Citation

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. Erratum in: Am J Epidemiol. 2003 May 1;157(9):858. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is persistence and recurrence of anal warts as compared between the experimental and control groups.		Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment	Yes
Secondary	Excision of warts will also allow pathologic data to be gathered on anal intraepithelial neoplasia (AIN), a precursor lesion to anal cancer that is an associated finding in both immunosuppressed patients and those with anal warts.		Time of surgical treatment(s)	No