Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-01 @ 8:11 PM
Study NCT ID:
NCT04099433
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Oral Bacteriotherapy to Promote Anal HPV Clearance in HIV Positive Individuals
Sponsor:
University of Roma La Sapienza
Organization:
Study Overview
Official Title:
HPVinHIV: Study of Anal HPV Infection in the Setting of HIV Infected Individuals
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPVinHIV
Brief Summary:
Published studies suggest that oral probiotic intake can promote the clearance of HPV genital infection and HPV related genital dysplasia in HIV negative women. In the present randomized, double blind, placebo controlled study, investigators will evaluate the ability of oral bacterio-therapy to enhance the clearance of anal HPV infection and anal HPV related dysplasia in HIV infected subjects.
Participants will be evaluated for anal HPV infection and anal dysplasia before and after a 6 months course of daily investigational product intake (Viviomixx® or placebo). HPV infection rate and presence of dysplasia at baseline and at the end of the study will be compared.
Participants will be evaluated for anal HPV infection and anal dysplasia before and after a 6 months course of daily investigational product intake (Viviomixx® or placebo). HPV infection rate and presence of dysplasia at baseline and at the end of the study will be compared.
Detailed Description:
Squamous Cell Carcinoma (SCC) of the anus and the anal canal represents a major concern for the HIV infected population, with incidence rates in the different sub populations (women, men, MSM) that are grater than those observed for other common neoplasms in the same HIV negative sub-populations. Nowadays, screening for anal precancerous dysplasia has been included in most national and international HIV management guidelines; in particular, italian guidelines suggest to screen for the presence of HPV related dysplasia:
* HIV+ MSM
* All individuals with previous or current evidence of ant-genital condyloma
* Women with cytology abnormalities on cervical Pap-smear Since no direct anti-HPV drug is currently available and control or clearance of the infection is possible only trough the effect of immune response, interest is addressed to find strategies to promote spontaneous clearance of infection.
In published studies, oral bacterio-therapy demonstrated the ability to promote HPV clearance and HPV related dysplasia regression in HIV negative women.
In the present randomized, double blind, placebo controlled trial, 40 HIV infected individuals with HPV related anal dysplasia will be enrolled.
At baseline participants will undergo:
* anal HPV research and identification
* anal cytology
* anal brushing for evaluation of local inflammatory milieu and microbiota
Subjects with identified HPV anal infection and anal dysplasia will undergo High Resolution Anoscopy (HRA).
During HRA, extra biopsies of identified abnormal areas and biopsies of normal mucosa will be obtained. Extra biopsies will be used to investigate the distribution of intra-epithelial immune cells populations.
Participants will then undergo 6 months of oral supplementation with probiotics (Vivomixx®) or placebo.
At the end of the supplementation period (Vivomixx or placebo), participants will undergo:
* anal HPV research and identification
* anal cytology
* anal brushing for evaluation of local inflammatory milieu and microbiota
* HRA
During HRA, extra biopsies of identified abnormal areas and biopsies of normal mucosa will be obtained. Extra biopsies will be used to investigate the distribution of intra-epithelial immune cells populations.
* HIV+ MSM
* All individuals with previous or current evidence of ant-genital condyloma
* Women with cytology abnormalities on cervical Pap-smear Since no direct anti-HPV drug is currently available and control or clearance of the infection is possible only trough the effect of immune response, interest is addressed to find strategies to promote spontaneous clearance of infection.
In published studies, oral bacterio-therapy demonstrated the ability to promote HPV clearance and HPV related dysplasia regression in HIV negative women.
In the present randomized, double blind, placebo controlled trial, 40 HIV infected individuals with HPV related anal dysplasia will be enrolled.
At baseline participants will undergo:
* anal HPV research and identification
* anal cytology
* anal brushing for evaluation of local inflammatory milieu and microbiota
Subjects with identified HPV anal infection and anal dysplasia will undergo High Resolution Anoscopy (HRA).
During HRA, extra biopsies of identified abnormal areas and biopsies of normal mucosa will be obtained. Extra biopsies will be used to investigate the distribution of intra-epithelial immune cells populations.
Participants will then undergo 6 months of oral supplementation with probiotics (Vivomixx®) or placebo.
At the end of the supplementation period (Vivomixx or placebo), participants will undergo:
* anal HPV research and identification
* anal cytology
* anal brushing for evaluation of local inflammatory milieu and microbiota
* HRA
During HRA, extra biopsies of identified abnormal areas and biopsies of normal mucosa will be obtained. Extra biopsies will be used to investigate the distribution of intra-epithelial immune cells populations.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: