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HivSaturne-HIVNCT04653610

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

An observational study of Hiv, run by University Hospital, Ghent at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hiv
How many people
105 participants
Where
1 siteBelgium
Study dates
27 Jan 2021to 1 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Our aim is to enroll a minimum of 32 and a maximum of 50 untreated HIV-infected patients. We aim to include a minimum of 16 patients 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. Of the HIV-infected patients, we aim to include 12 patients undergoing additional sampling consisting of lymph node excisions and an ileocolonoscopy (see below). Furthermore we aim to include 55 HIV-negative "healthy donors", from which we will collect inguinal lymph node samples, gut biopsies, a blood draw or leukapheresis and stool sample to confirm that the results found in HIV-patients are related to the disease. HIV seronegative participants can choose which procedures they would like to undergo, it is not necessary to undergo all study-related procedures. Before sampling, patients and healthy volunteers willing to participate will be enrolled following informed consent.

  1. 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:
  1. Confirmed hemoglobin <11g/dl for women and <12 g/dl for men
  2. Confirmed platelet count < 100 000/µl
  3. Confirmed neutrophil count <1000/μl
  4. 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)
  1. 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:
  1. Confirmed hemoglobin <11g/dl for women and <12 g/dl for men
  2. Confirmed platelet count < 100 000/µl
  3. Confirmed neutrophil count <1000/μl
  4. 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Linos Vandekerckhove, Prof. Dr. contact

+3293323398

linos.vandekerckhove@ugent.be

Belgium1 site, 1 recruiting

  • Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

    Linos Vandekerckhove, Prof. Dr., +3293323398, linos.vandekerckhove@ugent.be

    Recruiting

Other trials in Belgium

About this study

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.

Conditions
Hiv
Keywords
HIV, Extracellular Vesicles
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

Study groups in NCT04653610
Study groupRoleWhat they receive
HIV-infected individualsNot described
HIV-seronegative healthy volunteersNot described

What is being measured

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

  1. Extracellular Vesicles analysis-NTA

    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.

    Measured: 6 years

  2. Extracellular Vesicles analysis-microscopy

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

    Measured: 6 years

  3. Extracellular Vesicles analysis-western blot

    The isolated EVs will be further characterized through western blot.

    Measured: 6 years

  4. Extracellular Vesicles analysis-PCR

    The isolated EVs will be further characterized through PCR.

    Measured: 6 years

  5. Extracellular Vesicles analysis-proteomics

    The isolated EVs will be further characterized through proteomic analysis.

    Measured: 6 years

  6. Extracellular Vesicles analysis-RNAsequencing

    The isolated EVs will be further characterized through RNA sequencing.

    Measured: 6 years

  7. Extracellular Vesicles analysis-reporter assays

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

    Measured: 6 years

  8. Quantification of HIV DNA and RNA

    Digital PCR

    Measured: 6 years

  9. Immunological analysis-FACS

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

    Measured: 6 years

  10. Immunological analysis-ELISA

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

    Measured: 6 years

  11. Gene expression analysis/transcriptomics

    Measured: 6 years

  12. Microbiome monitoring

    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

    Measured: 6 years

  13. Virological analysis-FLIPS

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

    Measured: 6 years

  14. Virological analysis-integration site

    HIV will be characterized by integration site analysis.

    Measured: 6 years

Timeline

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

  1. First posted4 Dec 2020
  2. Study start27 Jan 2021
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653610
Sponsor's protocol ID
BC-08408
Acronym
Saturne-HIV
Status last verified
Feb 2024
First submitted
23 Oct 2020
Last updated
8 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hiv, run by University Hospital, Ghent at 1 site in Belgium.

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

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 8 Feb 2024. 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 Belgium. 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. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Linos Vandekerckhove, Prof. Dr. (+3293323398, linos.vandekerckhove@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extracellular Vesicles analysis-NTA (time frame: 6 years). The study lists 14 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 NCT04653610.

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 8 Feb 2024.

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