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Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622177
Recruitment Status : Not yet recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
HIV I Infection Procedure: biopsie Biological: blood drawn

Study Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection : a Prospective Cross-sectional Observational Study
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
HIV+ Procedure: biopsie
Additional colorectal mucosal biopsies during rectoscopy or colonoscopy

Biological: blood drawn
Additional blood drawn by venepuncture
HIV- STI+ Procedure: biopsie
Additional colorectal mucosal biopsies during rectoscopy or colonoscopy
HIV- STI- Procedure: biopsie
Additional colorectal mucosal biopsies during rectoscopy or colonoscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 ]
  3. Study of fibrosis markers in the intestinal mucosa [ Time Frame: through study completion, an average of 1 year ]
  4. In vitro functional analysis of amphiregulin from isolated CTL of the lamina propria [ Time Frame: through study completion, an average of 1 year ]

Secondary Outcome Measures :
  1. Characterization of HIV reservoir of the digestive mucosa [ Time Frame: through study completion, an average of 1 year ]
    (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

  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

  1. 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)

    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)

  2. 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)

  3. 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:

Inclusion criteria

  • 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)

Exclusion Criteria for the 3 groups

  • - 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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT03622177    
Other Study ID Numbers: ANRS EP65 AMVIH
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
HIV Infections
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases