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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00941889
First received: July 16, 2009
Last updated: August 14, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
HIV Positive
Anal Condylomata
Anal Warts
HIV Infections
Drug: Saline
Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The primary endpoint of this study is persistence and recurrence of anal warts as compared between the experimental and control groups. [ Time Frame: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 Frame: Time of surgical treatment(s) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.
Drug: Saline
0.5 ml
Active Comparator: Treatment group
The treatment group will receive a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
Drug: 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.
Other Name: GARDASIL

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941889

Locations
United States, Missouri
Washington University in St. Louis, Section of Colon Rectal Surgery
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Steven R Hunt, MD Washington University in St. Louis, School of Medicine
  More Information

Publications:
StatBite: Prevalence of HPV in a cohort of U.S. men. J Natl Cancer Inst. 2009 Feb 18;101(4):223.
Chitale R. Merck hopes to extend gardasil vaccine to men. J Natl Cancer Inst. 2009 Feb 18;101(4):222-3. Epub 2009 Feb 10.
Gillespie MB, Smith J, Gibbs K, McRackan T, Rubinchik S, Day TA, Sutkowski Human papillomavirus and head and neck cancer: a growing concern. N. J S C Med Assoc. 2008 Dec;104(8):247-51. Review.
Dunne E F, Markowitz L E. Genital Human Papillomavirus Infection. Clin Inf Dis 2006;43:624-9
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

Responsible Party: Dr. Steven R. Hunt, Washington University in St. Louis, School of Medicine
ClinicalTrials.gov Identifier: NCT00941889     History of Changes
Other Study ID Numbers: HRPO 07-0648
Study First Received: July 16, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
HIV
HPV
Anal condylomata
Vaccine
HIV positive patients
Anal condylomata or anal warts

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Condylomata Acuminata
HIV Infections
HIV Seropositivity
Recurrence
Disease Attributes
DNA Virus Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Papillomavirus Infections
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Slow Virus Diseases
Tumor Virus Infections
Virus Diseases
Warts

ClinicalTrials.gov processed this record on October 23, 2014