A trial to evaluate the immunogenicity of vaccine against human papillomavirus in HIV-infected men who have sex with men. GESIDA 10017 Study
- Conditions
- AIDSTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2018-000215-24-ES
- Lead Sponsor
- Fundacion SEIMC-GESIDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 166
- Patients able to give their written consent to participate in the study.
- Understand the purpose of the study and be available to perform the visits stipulated in the protocol.
- Be =18 years and - Patient with chronic infection with HIV-1.
- Viral HIV load <50 copies / ml and CD4> 200 cells / uL for at least the last six months.
- Transgender men or women who have had insertive or receptive anal sex with other men
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 166
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Previous history of anal cancer.
- Have previously received any vaccine against HPV.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method