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NCT Number: NCT04653610

Sequential Analysis Before and After Treatment Initiation to Unravel the Role of Naturally Occurring Extracellular Vesicles in HIV Infection

This study aims to evaluate the role of extracellular vesicles in HIV-infection, by determining the expression profile and content of EVs before and after treatment initiation in HIV-infected patients, through extensive blood and tissue sampling (leukapheresis, stool sampling and colon biopsies). A one-time sampling (blood, stool, colon biopsies) will also be performed in HIV-seronegative healthy volunteers to confirm that results found in HIV-infected patients are related to the disease.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location status: Recruiting

Location contact

Linos Vandekerckhove, Prof. Dr.

CONTACT

[email protected]

+3293323398

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

A. HIV-infected individuals

A.1. Inclusion Criteria:

  • Documented untreated HIV-1 infection defined as followed: HIV-1-specific antibody+(western blot); p31+ (ELISA)
  • CD4 T cell count will be determined standard of care (SOC). A minimum of 16 patients will be included with a CD4 T cell count lower than 350 cells/µl and a minimum of 16 patients with a CD4 T cell count higher than 350 cells/µl
  • Able and willing to provide written informed consent
  • Age ≥ 18 years and ≤ 65 years
  • Ability to attend the complete schedule of assessments and patient visits as described in the schedule below
  • Ability and willingness to have blood, stool and colon samples collected and stored for 20 years after finalizing the study, and used for various research purposes

A.2. Exclusion Criteria:

  • Recent HIV-infection, early diagnosis
  • Previous or current history of opportunistic infection (AIDS defining events as defined in category C of the CDC clinical classification), consisting of chronic HIV-1 infection
  • Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody))
  • Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry
  • Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease
  • Current or known history of cancer
  • Pregnancy or breastfeeding
  • Any conditions, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant. An initial psychiatric assessment will be made by the treating physician. Since making a correct psychological assessment at the time of diagnosis can be difficult, a visit with a psychologist is planned for patients included in the study, for a second evaluation. This will be planned within the first month after diagnosis. In consultation with the psychologist, further sampling will be planned or the patient will be excluded from further sampling.
  • Previous participation in a trial evaluating an immune modulating agent
  • Abnormal laboratory tests results at screening:
  • Confirmed hemoglobin <11g/dl for women and <12 g/dl for men
  • Confirmed platelet count < 100 000/µl
  • Confirmed neutrophil count <1000/μl
  • Confirmed AST and/or ALT > 10x ULN
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry
  • Known inflammatory bowel disease (Crohn's disease or ulcerative colitis)

B. Healthy Volunteers

B.1. Inclusion Criteria:

  • Able and willing to provide written informed consent
  • Age ≥ 18 years and ≤ 65 years
  • Ability to attend the complete sampling schedule, as described below
  • Ability and willingness to have blood, stool and colon samples collected and stored for 20 years and used for various research purposes

B.2. Exclusion Criteria:

  • HIV-infection
  • Evidence of active HBV infection (Hepatitis B surface antigen positive or HBV viral load positive in the past and no evidence of subsequent seroconversion (=HBV antigen or viral load negative and positive HBV surface antibody))
  • Evidence of active HCV infection: HCV antibody positive result within 60 days prior to study entry with positive HCV viral load or, if the HCV antibody result is negative, a positive HCV RNA result within 60 days prior to study entry
  • Current or known history of cardiomyopathy or significant ischemic or cerebrovascular disease
  • Current or known history of cancer
  • Pregnancy or breastfeeding
  • Any conditions, including preexisting psychiatric and psychological disorders, which will in the opinion of the investigator interfere with the trial conduct or safety of the participant
  • Previous participation in a trial evaluating an immune modulating agent
  • Abnormal laboratory tests results at screening:
  • Confirmed hemoglobin <11g/dl for women and <12 g/dl for men
  • Confirmed platelet count < 100 000/µl
  • Confirmed neutrophil count <1000/μl
  • Confirmed AST and/or ALT > 10xULN
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Acute or serious illness, in the opinion of the site investigator, requiring systemic treatment and/or hospitalization within 60 days prior to entry
  • Known inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Treatment and study plan

Primary outcomes

  1. Extracellular Vesicles analysis-NTA

    Time frame: 6 years

    Extracellular vesicles (EV) will be isolated through a combination of size-exclusion chromatography (SEC) and Optiprep density gradient (ODG). Nanoparticle Tracking Analysis (NTA) will be performed to obtain the concentration and size distribution of EVs in the samples.

  2. Extracellular Vesicles analysis-microscopy

    Time frame: 6 years

    The isolated EVs will be further visualized by (electron) microscopy.

  3. Extracellular Vesicles analysis-western blot

    Time frame: 6 years

    The isolated EVs will be further characterized through western blot.

  4. Extracellular Vesicles analysis-PCR

    Time frame: 6 years

    The isolated EVs will be further characterized through PCR.

  5. Extracellular Vesicles analysis-proteomics

    Time frame: 6 years

    The isolated EVs will be further characterized through proteomic analysis.

  6. Extracellular Vesicles analysis-RNAsequencing

    Time frame: 6 years

    The isolated EVs will be further characterized through RNA sequencing.

  7. Extracellular Vesicles analysis-reporter assays

    Time frame: 6 years

    Reporter assays will be performed to quantitatively measure bacterial EV-associated lipopolysaccharide (LPS).

  8. Quantification of HIV DNA and RNA

    Time frame: 6 years

    Digital PCR

  9. Immunological analysis-FACS

    Time frame: 6 years

    Immunophenotyping by flow cytometric assays will be performed of different cells to assess the phenotype of innate immune cells, using FACS analysis.

  10. Immunological analysis-ELISA

    Time frame: 6 years

    Immunophenotyping by flow cytometric assays will be performed of different cells to assess the phenotype of innate immune cells, using ELISA.

  11. Gene expression analysis/transcriptomics

    Time frame: 6 years

  12. Microbiome monitoring

    Time frame: 6 years

    Gut microbiome will be analyzed in stool and colon biopsies using next-generation sequencing (NGS) of rRNA gene amplicons to identify bacteria at genus/species level

  13. Virological analysis-FLIPS

    Time frame: 6 years

    HIV will be characterized by Full Length Individual Proviral Sequencing (FLIPS).

  14. Virological analysis-integration site

    Time frame: 6 years

    HIV will be characterized by integration site analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Linos Vandekerckhove, Prof. Dr.

CONTACT

[email protected]

+3293323398

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: Saturne-HIV

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2020
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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