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Immune Response to HPV Vaccine in HIV-1 Infected Men
NCT02236234Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2012
- Primary completion
- Jan 2013
- Countries
- 1
- Sponsor
- Universidade de São Paulo
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- human papillomavirus infection
01
Overview
Phase 4, open-label trial of human papillomavirus type 16 L1 capsid protein antigen in human papillomavirus infection (3 arms), sponsored by Universidade de São Paulo. Primary endpoint: Presence of Anti-HPV antibody titers at 180 days. Started Jan 2012; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
HIV-1 Infected (CD4 > 500)
HIV-1 infected men with CD4 count > 500 cells/mm3 receiving HPV vaccine
HIV-1 Infected (CD4 < 500)
HIV-1 infected men with CD4 count < 500 cells/mm3 receiving HPV vaccine
Healthy Control
Healthy men receiving HPV vaccine
03
Who it enrols
Men aged 35-45 years. Inclusion criteria: HIV-1 infection (stratified by CD4 count >500 or <500 cells/mm3) or healthy volunteers. Exclusion criteria: Current or previous infection with human papillomavirus (HPV).
04
Endpoints
Primary
Presence of Anti-HPV antibody titers
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