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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00941889
First received: July 16, 2009
Last updated: June 13, 2016
Last verified: June 2016

July 16, 2009
June 13, 2016
July 2007
July 2011   (final data collection date for primary outcome measure)
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 ]
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.
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 ]
Complete list of historical versions of study NCT00941889 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HIV Positive
  • Anal Condylomata
  • Anal Warts
  • HIV Infections
  • Drug: Saline
    0.5 ml
  • 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
  • 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.
    Intervention: Drug: Saline
  • 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.
    Intervention: Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00941889
HRPO 07-0648
No
No
No outcomes data were collected or analyzed due to lack of participant follow-up.
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Steven R Hunt, MD Washington University School of Medicine
Washington University School of Medicine
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP