HIV I InfectionNCT03622177
Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection
An observational study of HIV I Infection, run by ANRS, Emerging Infectious Diseases.
Trial summary
Interleukin33 organize local immune reactions, especially at epithelial barriers. ST2 is the IL33 receptor. The sST2 rate is higher for patient living with HIV and is an independent predictable factor of mortality. Interleukin33 induce tissue Treg ST2+ lymphocytes proliferation and amphireguline production. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV I Infection
- What is being tested?
- biopsie and blood drawn
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Sep 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: people living with HIV compare to people who are not living with HIV : - people with high burden of STI / people without burden of STI
Who may be able to join
- Group 1: HIV-infected subjects
- HIV-1 infection
- Age ≥ 18 years old
- CD4 count≥ 100/mm3
- Receiving an active antiretroviral treatment (plasma HIV viral load ≤ 50 copies/ml)
- Subjects needing an STI screening for routine care including rectal biopsy (independently of the current study protocol)
Show all 18Show fewer
- NB : an additional inclusion criteria for the Group 1 will be defined after the "phase 0" which will define two levels of fibrosis (low / high)
- Group 2: controls not infected with HIV needing a rectoscopy for an STI screening
- HIV negative
- Age ≥ 18 years old
- Subjects needing an STI screening for routine care including rectal biopsy (independently of the current study protocol)
- Group 3: controls not infected with HIV needing a colonoscopy
- HIV negative
- Age ≥ 18 years old
- Subjects needing a colonoscopy with colorectal biopsy as part of routine care (independently of the current study protocol)
- For the 3 groups:
- Affiliated or beneficiary of a Social Security coverage
- Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of pre-inclusion and before any examination carried out within the framework of the trial)
Who cannot join
- - HIV-2 infection or HIV-1 \& HIV-2 co-infection
- Active infection or cancer
- Contraindication to rectal biopsies (coagulation disorders, anticoagulation therapy, anorectal surgery, inflammatory bowel disease, post-radial rectitis)
- Subject participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
- Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
- Pregnant or breastfeeding women
- Replicative HCV or HBV infection
About this study
Official title: Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection : a Prospective Cross-sectional Observational Study
Interleukin33 organize local immune reactions, especially at epithelial barriers.
ST2 is the IL33 receptor. The sST2 rate is higher for patient living with HIV and is an independent predictable factor of mortality. Interleukin33 induce tissue Treg ST2+ lymphocytes proliferation and amphireguline production. Amphireguline is member of epithelial growth factors family, which contributes to tissue repair, and fibrose. Amphireguline also helps immunosuppressives functions. Targetting amphiregulin for people living with HIV who has poor restauration of LTCD4+ could be a future therapy.
- Conditions
- HIV I Infection
- Being tested
- biopsie, blood drawn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsieProcedure or surgery
Additional colorectal mucosal biopsies during rectoscopy or colonoscopy
blood drawnBiological
Additional blood drawn by venepuncture
| Study group | Role | What they receive |
|---|---|---|
| HIV+ | Not described Receives: Procedure: biopsie; Biological: blood drawn | |
| HIV- STI+ | Not described Receives: Procedure: biopsie | |
| HIV- STI- | Not described Receives: Procedure: biopsie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of amphiregulin plasma levels
Quantification of amphiregulin plasma levels in HIV-infected subjects and correlation these levels with blood TCD4 cell count and clinical parameters (cardiac diastolic dysfunction, organ dysfunctions likely to be secondary to fibrosis phenomena) recorded in the CARDAMONE cohort.
Measured: through study completion, an average of 1 year
Phenotypic characterization of gut Treg cells and CD8+ T lymphocytes (CTL) isolated from the intestinal mucosa
Measured: through study completion, an average of 1 year
Study of fibrosis markers in the intestinal mucosa
Measured: through study completion, an average of 1 year
In vitro functional analysis of amphiregulin from isolated CTL of the lamina propria
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Characterization of HIV reservoir of the digestive mucosa
(i) Analysis at the blood and digestive compartment (rectum) for different CD4 CD32a T lymphocyte populations, marker of the viral reservoir; (ii) Quantification HIV DNA and the HIV reservoir competent for replication from blood and gut
Measured: through study completion, an average of 1 year
Determination of antiretroviral drugs levels in digestive tissue and in plasma and correlation between antiretroviral drugs levels and viral reservoir and lymphocyte phenotype
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV I InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622177
- Sponsor's protocol ID
- ANRS EP65 AMVIH
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection : a Prospective Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT03622177
- Acronym / sponsor ID
- ANRS EP65 AMVIH
- Conditions
- HIV I Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interleukin33 organize local immune reactions, especially at epithelial barriers.
ST2 is the IL33 receptor. The sST2 rate is higher for patient living with HIV and is an independent predictable factor of mortality. Interleukin33 induce tissue Treg ST2+ lymphocytes proliferation and amphireguline production. Amphireguline is member of epithelial growth factors family, which contributes to tissue repair, and fibrose. Amphireguline also helps immunosuppressives functions. Targetting amphiregulin for people living with HIV who has poor restauration of LTCD4+ could be a future therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV+ | – | Procedure: biopsie, Biological: blood drawn |
| HIV- STI+ | – | Procedure: biopsie |
| HIV- STI- | – | Procedure: biopsie |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people living with HIV compare to people who are not living with HIV : - people with high burden of STI / people without burden of STI
Key inclusion criteria (18 listed)
- Group 1: HIV-infected subjects
- NB : an additional inclusion criteria for the Group 1 will be defined after the "phase 0" which will define two levels of fibrosis (low / high)
- Group 2: controls not infected with HIV needing a rectoscopy for an STI screening
- Group 3: controls not infected with HIV needing a colonoscopy
- Affiliated or beneficiary of a Social Security coverage
Key exclusion criteria (7 listed)
- - HIV-2 infection or HIV-1 \& HIV-2 co-infection
- Active infection or cancer
- Contraindication to rectal biopsies (coagulation disorders, anticoagulation therapy, anorectal surgery, inflammatory bowel disease, post-radial rectitis)
- Subject participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
- Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsieAdditional colorectal mucosal biopsies during rectoscopy or colonoscopy | Procedure or surgery | HIV+, HIV- STI+, HIV- STI- |
| blood drawnAdditional blood drawn by venepuncture | Biological | HIV+ |
Primary outcome
Quantification of amphiregulin plasma levels
Time frame: through study completion, an average of 1 year
Quantification of amphiregulin plasma levels in HIV-infected subjects and correlation these levels with blood TCD4 cell count and clinical parameters (cardiac diastolic dysfunction, organ dysfunctions likely to be secondary to fibrosis phenomena) recorded in the CARDAMONE cohort.
Phenotypic characterization of gut Treg cells and CD8+ T lymphocytes (CTL) isolated from the intestinal mucosa
Time frame: through study completion, an average of 1 year
Study of fibrosis markers in the intestinal mucosa
Time frame: through study completion, an average of 1 year
In vitro functional analysis of amphiregulin from isolated CTL of the lamina propria
Time frame: through study completion, an average of 1 year
2 secondary outcomes
Characterization of HIV reservoir of the digestive mucosa
Time frame: through study completion, an average of 1 year
Determination of antiretroviral drugs levels in digestive tissue and in plasma and correlation between antiretroviral drugs levels and viral reservoir and lymphocyte phenotype
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV I Infection, run by ANRS, Emerging Infectious Diseases.
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 18 inclusion and 7 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of amphiregulin plasma levels (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2018.