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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00941889
Recruitment Status : Completed
First Posted : July 20, 2009
Results First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Information provided by (Responsible Party):

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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata
Study Start Date : July 2007
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
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.
Drug: Saline
0.5 ml
Active Comparator: Gardasil
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.
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941889

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
Principal Investigator: Steven R Hunt, MD Washington University School of Medicine
More Information

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: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00941889     History of Changes
Other Study ID Numbers: HRPO 07-0648
First Posted: July 20, 2009    Key Record Dates
Results First Posted: July 25, 2016
Last Update Posted: July 25, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No outcomes data were collected or analyzed due to lack of participant follow-up.

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

Additional relevant MeSH terms:
HIV Infections
HIV Seropositivity
Condylomata Acuminata
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes
Papillomavirus Infections
DNA Virus Infections
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs