The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
Washington University School of Medicine
Information provided by (Responsible Party)
Washington University School of Medicine
First received: July 16, 2009
Last updated: June 13, 2016
Last Verified: June 2016
History of Changes
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.
Drug : Saline
Drug : Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
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|
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 ]
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.
|Study Start Date:||July 2007|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
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.
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
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
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.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- ≥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.
- 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 LocationsChoosing 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 Show More
|United States, Missouri|
|Washington University in St. Louis, Section of Colon Rectal Surgery|
|St. Louis, Missouri, United States, 63110|
Sponsors and CollaboratorsWashington University School of Medicine
|Principal Investigator:||Steven R Hunt, MD||Washington University School of Medicine|
|Responsible Party:||Washington University 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:||June 13, 2016|
|Individual Participant Data|
|Plan to Share IPD:||No|
Keywords provided by Washington University School of Medicine:HIV
HIV positive patients
Anal condylomata or anal warts
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.