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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2021-07-14

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A phase IV, open-label and single-arm clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Men infected by HIV who have sex with men

Group Type EXPERIMENTAL

HPV9v

Intervention Type BIOLOGICAL

Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24

Interventions

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HPV9v

Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24

Intervention Type BIOLOGICAL

Other Intervention Names

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Gardasil9

Eligibility Criteria

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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