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

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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

Tracking Information
First Submitted Date August 3, 2018
First Posted Date August 9, 2018
Last Update Posted Date August 9, 2018
Estimated Study Start Date September 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2018)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 7, 2018)
  • 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
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection
Official Title Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection : a Prospective Cross-sectional Observational Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition HIV I Infection
Intervention
  • Procedure: biopsie
    Additional colorectal mucosal biopsies during rectoscopy or colonoscopy
  • Biological: blood drawn
    Additional blood drawn by venepuncture
Study Groups/Cohorts
  • HIV+
    Interventions:
    • Procedure: biopsie
    • Biological: blood drawn
  • HIV- STI+
    Intervention: Procedure: biopsie
  • HIV- STI-
    Intervention: Procedure: biopsie
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 7, 2018)
180
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03622177
Other Study ID Numbers ANRS EP65 AMVIH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party ANRS, Emerging Infectious Diseases
Study Sponsor ANRS, Emerging Infectious Diseases
Collaborators Not Provided
Investigators Not Provided
PRS Account ANRS, Emerging Infectious Diseases
Verification Date August 2018