AzTrials
AzTrials

HIVHPVinHIVNCT04099433

Application of Oral Bacteriotherapy to Promote Anal HPV Clearance in HIV Positive Individuals

A study testing Vivomixx in people with HIV and Anal Dysplasia, run by University of Roma La Sapienza at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Anal Dysplasia
What is being tested?
Vivomixx
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteItaly
Study dates
1 Mar 2019to 1 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HIV infected individuals >18 years old
  • stable and effective antiretroviral therapy since at least 12 months
  • HPV associated anal dysplasia
  • patient willing to provide written informed consent

Who cannot join

  • impossibility to intake the investigational product
  • any contraindication to blood sampling
  • inflammatory bowel disease
  • use of antibiotics during the 3 months prior to the enrollment in the study
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Gabriella d'Ettorre, Professor, MD contact

0649970801

gabriella.dettorre@uniroma1.it

Eugenio Nelson Cavallari, MD contact

eugenionelson.cavallari@uniroma1.it

Italy1 site, 1 recruiting

  • Department of Pubblic Health and Infectious Diseases, "Sapienza" University of Rome

    Rome, RM, 00100

    Gabriella d'Ettorre, Professor, gabriella.dettorre@uniroma1.it

    Eugenio Nelson Cavallari, MD, eugenionelson.cavallari@uniroma1.it

    Recruiting

Other trials in Italy

About this study

Official title: HPVinHIV: Study of Anal HPV Infection in the Setting of HIV Infected Individuals

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.

Read the 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.

Conditions
HIV, Anal Dysplasia
Being tested
Vivomixx, Placebo
Keywords
HIV, HPV, Probiotics, High Resolution Anoscopy, Anal dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VivomixxDietary supplement

    Individuals in the interventional arm will undergo daily oral intake of probiotic supplement

  • PlaceboOther

    Individuals in the placebo arm will undergo daily oral intake of placebo supplement

Study groups in NCT04099433
Study groupRoleWhat they receive
Oral Bacteriotherapy ArmExperimentalIndividuals in this study arm will undergo 6 months of daily intake of an oral probiotic formulation (Vivomixx: 4 sachets/day, each sachet containing 450 billion live bacteria). Probiotic sachets are indistinguishable from placebo
Receives: Dietary Supplement: Vivomixx
Placebo ArmPlacebo comparatorIndividuals in this study arm will undergo 6 months of daily intake of placebo (4 sachets/day). Placebo sachets are indistinguishable from probiotic
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the number of HPV positive anal swabs

    Clearance of anal HPV infection will be defined as:

    • negative swab at the end of the study in participants with positive swab at baseline
    • positive swab at the end of the study that shows a different genotype from baseline

    Measured: Anal swabs for HPV detection and genotyping will be performed at baseline and after the 6 months duration of the intervention

  2. Change from baseline in the number of dysplastic lesions

    Clearance of anal dysplasia will be defined as:

    • normal histology in biopsies repeated at the end of the study on areas that showed the presence of histologically defined dysplasia at baseline.

    Measured: Areas of the anal canal that were biopsied at baseline and whom histology showed the presence of dysplasia will undergo a second biopsy after the 6 months duration of the intervention

Secondary outcomes (4)

  1. Rate of adverse events

    The rate of adverse events occurred during the study period will be evaluated and compared between both groups

    Measured: This measure will be assessed after the 6 months duration of the intervention

  2. Comparison between intra-epithelial NK lymphocytes subpopulation in normal mucosa and dysplastic mucosa

    Biopsies from dysplastic lesions and from normal mucosa will be taken at baseline. Biopsies will also be taken at the end of the study from previously biopsied areas, from normal mucosa and eventually from dysplastic areas that were not present at baseline. Intra-epithelial lymphocytes will be extracted from the biopsy tissue and stained to differentiate and quantify CD56+NK lymphocytes by flowcytometry. Changes from baseline will be expressed as relative difference.

    Measured: Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention

  3. Comparison between intra-epithelial CD4+ T lymphocytes subpopulation in normal mucosa and dysplastic mucosa

    Biopsies from dysplastic lesions and from normal mucosa will be taken at baseline. Biopsies will also be taken at the end of the study from previously biopsied areas, from normal mucosa and eventually from dysplastic areas that were not present at baseline. Intra-epithelial lymphocytes will be extracted from the biopsy tissue and stained to differentiate and quantify CD4+ T lymphocytes by flowcytometry. Changes from baseline will be expressed as relative difference.

    Measured: Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention

  4. Comparison between intra-epithelial CD8+ T lymphocytes subpopulation in normal mucosa and dysplastic mucosa

    Biopsies from dysplastic lesions and from normal mucosa will be taken at baseline. Biopsies will also be taken at the end of the study from previously biopsied areas, from normal mucosa and eventually from dysplastic areas that were not present at baseline. Intra-epithelial lymphocytes will be extracted from the biopsy tissue and stained to differentiate and quantify CD8+ T lymphocytes by flowcytometry. Changes from baseline will be expressed as relative difference.

    Measured: Biopsies and intra-epithelial lymphocytes extraction will be performed at baseline and after the 6 months duration of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Mar 2020 (estimated)
  4. Study completion1 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04099433
Sponsor's protocol ID
4590
Acronym
HPVinHIV
Status last verified
Sep 2019
First submitted
24 Jun 2019
Last updated
23 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pedersen TB, Pachler FR, Rosenberg J, Andresen K. Interventions for anal canal intraepithelial neoplasia. Cochrane Database Syst Rev. 2025 Aug 13;8(8):CD009244. doi: 10.1002/14651858.CD009244.pub3.

    PubMed 40801169

Questions about this trial

What is this clinical trial studying?

A study testing Vivomixx in people with HIV and Anal Dysplasia, run by University of Roma La Sapienza at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gabriella d'Ettorre, Professor, MD (0649970801, gabriella.dettorre@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the number of HPV positive anal swabs (time frame: Anal swabs for HPV detection and genotyping will be performed at baseline and after the 6 months duration of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04099433, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in