Status:
UNKNOWN
Long Term Immunogenicity of Quadrivalent Human Papillomavirus Vaccine (Gardasil®)in HIV-infected Adolescents and Young Adults
Lead Sponsor:
University of Milan
Conditions:
HPV
HIV
Eligibility:
All Genders
13-27 years
Phase:
PHASE3
Brief Summary
Infection with human immunodeficiency virus (HIV) is an important risk factor for HPV infection and the development of HPV-associated lesions in female and male anogenital tract. Data on safety and im...
Eligibility Criteria
Inclusion
- For both HIV-infected and healthy subjects:
- Subjects aged 13-27 years, females and males
- Written informed consent from parent or guardian if applicable (age\<18 years)
- For HIV-infected subjects:
- HIV-positive
- Asymptomatic subjects (generalized lymphadenopathy is accepted)
- Lymphocyte CD4+ count \> or equal to 350 cells/mm3
- For subjects receiving HAART:
- Good compliance to therapy
- At least two suppressed viral loads HIV-RNA (\<37copies/ml9 during 6 months prior to enrollment.
Exclusion
- For female subjects (both HIV-infected and healthy)
- Pregnancy or breastfeeding
- Total hysterectomy. Participants who have undergone partial hysterectomy and have a cervix are not excluded.
- For both females and males (HIV-infected and healthy):
- Prior vaccination with quadrivalent HPV vaccine Gardasil before study entry.
- History of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component.
- Any serious chronic or progressive disease (other than HIV) according to the judgment of the investigator:
- Acute infection requiring therapy or fever at time of enrollment
- Chronic autoimmune or oncologic disease receiving chemotherapy
- Concomitant therapies (other than HAART):
- Chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry.
- Use of investigational agents within 4 weeks prior to study enrollment.
- Current drug or alcohol use or dependence.
- Documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01512784
Start Date
October 1 2011
End Date
July 1 2013
Last Update
January 19 2012
Active Locations (1)
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1
Luigi Sacco Hospital , Department of Paediatrics, via G.B Grassi, 74
Milan, Italy, Italy, 20157