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

18 Years
Open (Enrolling by invite only)
HIV Positive, Anal Condylomata, Anal Warts, HIV Infections

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

The primary endpoint of this study is persistence and recurrence of anal warts as compared between the experimental and control groups.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Steven R Hunt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University in St. Louis, School of Medicine


United States: Institutional Review Board

Study ID:

HRPO 07-0648



Start Date:

July 2007

Completion Date:

July 2011

Related Keywords:

  • HIV Positive
  • Anal Condylomata
  • Anal Warts
  • HIV Infections
  • HIV
  • HPV
  • Anal condylomata
  • Vaccine
  • HIV positive patients
  • Anal condylomata or anal warts
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Condylomata Acuminata
  • HIV Seropositivity
  • Recurrence



Washington University in St. Louis, Section of Colon Rectal Surgery St. Louis, Missouri  63110