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

Primary Purpose

HIV Positive, Anal Condylomata, Anal Warts

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Saline

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

About this trial

This is an interventional treatment trial for HIV Positive focused on measuring HIV, HPV, Anal condylomata, Vaccine, HIV positive patients, Anal condylomata or anal warts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Washington University in St. Louis, Section of Colon Rectal Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Gardasil

Arm Description

Patients who are in the control group received a placebo of saline in the upper extremity at initial visit, 2 months and 6 months after enrollment.

The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity at initial visit, and again at two months and six months after enrollment.

Outcomes

Primary Outcome Measures

The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.

Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.

Secondary Outcome Measures

Full Information

NCT ID

NCT00941889

First Posted

July 16, 2009

Last Updated

June 13, 2016

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00941889

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Positive, Anal Condylomata, Anal Warts, HIV Infections

Keywords

HIV, HPV, Anal condylomata, Vaccine, HIV positive patients, Anal condylomata or anal warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients who are in the control group received a placebo of saline in the upper extremity at initial visit, 2 months and 6 months after enrollment.

Arm Title

Gardasil

Arm Type

Active Comparator

Arm Description

The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity at initial visit, and again at two months and six months after enrollment.

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

0.5 ml

Intervention Type

Drug

Intervention Name(s)

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Other Intervention Name(s)

GARDASIL

Intervention Description

0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.

Primary Outcome Measure Information:

Title

The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.

Description

Time Frame

Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven R Hunt, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University in St. Louis, Section of Colon Rectal Surgery

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No outcomes data were collected or analyzed due to lack of participant follow-up.

Citations:

PubMed Identifier

19211451

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. No abstract available.

Results Reference

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PubMed Identifier

19360985

Citation

Human papillomavirus vaccines. WHO position paper. Wkly Epidemiol Rec. 2009 Apr 10;84(15):118-31. No abstract available. English, French.

Results Reference

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PubMed Identifier

19211446

Citation

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.

Results Reference

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PubMed Identifier

19326612

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.

Results Reference

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PubMed Identifier

18822547

Citation

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

Results Reference

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PubMed Identifier

18833082

Citation

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

Results Reference

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PubMed Identifier

18303060

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.

Results Reference

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PubMed Identifier

18512537

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. doi: 10.1177/009885880803400103. No abstract available.

Results Reference

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PubMed Identifier

16886157

Citation

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.

Results Reference

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PubMed Identifier

12543621

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. doi: 10.1093/aje/kwf180. Erratum In: Am J Epidemiol. 2003 May 1;157(9):858.

Results Reference

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PubMed Identifier

12516848

Citation

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.

Results Reference

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PubMed Identifier

15863374

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. doi: 10.1016/S1470-2045(05)70101-7.

Results Reference

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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

Results Reference

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

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