A Clinical Trial to Evaluate the Immunogenicity of the Nonavalent Vaccine Against Human Papillomavirus in Men Infected by HIV Who Have Sex With Men. GESIDA 10017 (GESIDA10017)

Fundacion SEIMC-GESIDA

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Biological: HPV9v

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03626467

GESIDA10017

Details and patient eligibility

About

Phase IV, open, multicenter and single-arm clinical trial designed to evaluate the immunogenicity of the HPV9v vaccine in men with HIV infection (HIV +) who have sex with men (MSM)

Full description

The investigators estimate that 166 participants will need to be included in the study to evaluate the immunogenicity of vaccine against human papillomavirus in men with HIV infection who have sex with men, by evaluating in two age groups and the seroconversion rate for each of the HPV genotypes included in the vaccine from baseline to month 7 and 24.

Enrollment

158 patients

Sex

Male

Ages

18 to 36 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients able to give their written consent to participate in the study. (preferably in writing or, failing that, orally before independent witnesses of the research team) after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment.
Understand the purpose of the study and be available to perform the visits stipulated in the protocol.
Be ≥18 years and <of 36 years.
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

Exclusion criteria