Status:
COMPLETED
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
Lead Sponsor:
Washington University School of Medicine
Conditions:
HIV Positive
Anal Condylomata
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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 can...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00941889
Start Date
July 1 2007
End Date
July 1 2011
Last Update
July 25 2016
Active Locations (1)
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1
Washington University in St. Louis, Section of Colon Rectal Surgery
St Louis, Missouri, United States, 63110