HIVMICRACTIVIHNCT05724524
Exploratory Study on the Role of the Digestive Microbiota in Adults Living With HIV-1
An observational study of HIV, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Chronic immune activation present in aviremic people living with HIV under treatment promotes the onset of insulin resistance and metabolic syndrome, paving the way for the comorbidities that are currently the main causes of morbidity. This activation continues despite effective antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Stool sample collection and Blood sample collection
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- May 2022to Feb 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult men with HIV-1 infection on effective antiretroviral therapy stable for more than 6 months.
Who may be able to join
- Patient informed of the implementation of the study, its objectives, its constraints and the patient's rights.
- Male and Caucasian patient.
- Patient with HIV-1 infection determined by positive serology or plasma viral load (HIV RNA) measurement.
- Patient on effective triple antiretroviral therapy, stable for more than 6 months, with a plasma viral load <50 copies / ml for at least 6 months before inclusion (2 measurements).
- Patient whose immune activation profile has been characterized beforehand (profiles 1, 2, 3, 4 and 5).
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- Vulnerable person according to article L1121-6 of the CSP.
- Adult person protected according to article L1121-8 of the CSP.
- Patient presenting with a non-infectious pathology which may be the cause of an immune abnormality.
- Patient having undergone treatment with an immunomodulator molecule or chemotherapy within 60 days before inclusion in the research or has an indication planned for the duration of the research.
- Patient with a chronic digestive pathology or who had been operated on the previous year
- The subject is participating in a category 1 interventional study, has participated in another interventional study in the last 3 months or is in a period of exclusion determined by a previous study
Show all 9Show fewer
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Exploratory Study on the Role of the Digestive Microbiota and Bacterial Translocation in the Immune Activation Profile Associated With Insulin Resistance in Male Caucasian Adults Living With HIV-1 on Effective Antiretroviral Therapy.
Chronic immune activation present in aviremic people living with HIV under treatment promotes the onset of insulin resistance and metabolic syndrome, paving the way for the comorbidities that are currently the main causes of morbidity. This activation continues despite effective antiretroviral therapy. In the ACTIVIH study (NCT02334943) the analysis of 68 AI markers allowed classification of 120 aviremic PLHIV under treatment for at least 2 years according to 5 different immune activation profiles. Among these 5 profiles, Profile 2 was characterized by high blood pressure figures, high waist sizes, low HDL-cholesterol levels, high triglyceridemia, and especially hyperinsulinemia. Several studies have shown that the digestive microbiota of this population is less rich and less diverse than that of healthy subjects. However, the digestive microbiota and in particular bacterial proteins and metabolites seem to play a key role in immune activation in people living with HIV. Finally, the digestive microbiota has already been shown to have an impact on insulin sensitivity.
The study investigators hypothesize that a particular digestive microbiota could promote the appearance of Profile 2. This microbiota could be the cause of digestive dysbiosis leading to intestinal inflammation, digestive permeability and bacterial translocation.
- Conditions
- HIV
- Being tested
- Stool sample collection, Blood sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sample collectionOther
50mg stool sample taken for protein extraction
Blood sample collectionOther
Venous blood sample taken for analysis of serum and plasma
| Study group | Role | What they receive |
|---|---|---|
| Profile 2 | People living with HIV with immune activation profile 2: inflammatory profile - high level of sTNFRI Receives: Other: Stool sample collection; Other: Blood sample collection | |
| Other profiles | People living with HIV with immune activation profiles1 + 3-5: T8, NK, T4 and monocyte profiles Receives: Other: Stool sample collection; Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles
Number of bacterial proteins present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry
Measured: Day 0
Nature of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles
Number of operational taxonomic units present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry
Measured: Day 0
Relative quantification of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles
Percentage of the various bacterial proteins present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry (%)
Measured: Day 0
Relative quantification of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles
Percentage of the various operational taxonomic units present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry (%)
Measured: Day 0
Secondary outcomes (9)
Richness of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
Rarefaction curves
Measured: Day 0
Diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
Shannon index
Measured: Day 0
beta-diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
Unifrac
Measured: Day 0
Level of phyla and minority species in the stool in patients with immune activation profile 2 versus all other profiles
high-performance liquid chromatography mass spectrometry
Measured: Day 0
Level of CD14S in serum of patients with immune activation profile 2 versus all other profiles
ng/ml by ELISA
Measured: Day 0
Level of Lipopolysaccharide Binding Protein (LBP) in serum of patients with immune activation profile 2 versus all other profiles
pg/ml by ELISA
Measured: Day 0
Level of intestinal fatty acid binding protein (I-FABP) in serum of patients with immune activation profile 2 versus all other profiles
ng/ml by ELISA
Measured: Day 0
Level of bacterial 16S rDNA in plasma of patients with immune activation profile 2 versus all other profiles
Copies/µl
Measured: Day 0
Transcriptomic analysis of peripheral blood mononuclear cells
RNAseq
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startMay 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: no started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Lavigne, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724524
- Sponsor's protocol ID
- AOI GCS-MERRI/2019/JPL-01
- Acronym
- MICRACTIVIH
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2022
- Last updated
- 13 Feb 2023
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Role of the Digestive Microbiota and Bacterial Translocation in the Immune Activation Profile Associated With Insulin Resistance in Male Caucasian Adults Living With HIV-1 on Effective Antiretroviral Therapy.
- ClinicalTrials.gov ID
- NCT05724524
- Acronym / sponsor ID
- MICRACTIVIH / AOI GCS-MERRI/2019/JPL-01
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 13 Feb 2023 (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.
Chronic immune activation present in aviremic people living with HIV under treatment promotes the onset of insulin resistance and metabolic syndrome, paving the way for the comorbidities that are currently the main causes of morbidity. This activation continues despite effective antiretroviral therapy. In the ACTIVIH study (NCT02334943) the analysis of 68 AI markers allowed classification of 120 aviremic PLHIV under treatment for at least 2 years according to 5 different immune activation profiles. Among these 5 profiles, Profile 2 was characterized by high blood pressure figures, high waist sizes, low HDL-cholesterol levels, high triglyceridemia, and especially hyperinsulinemia. Several studies have shown that the digestive microbiota of this population is less rich and less diverse than that of healthy subjects. However, the digestive microbiota and in particular bacterial proteins and metabolites seem to play a key role in immune activation in people living with HIV. Finally, the digestive microbiota has already been shown to have an impact on insulin sensitivity.
The study investigators hypothesize that a particular digestive microbiota could promote the appearance of Profile 2. This microbiota could be the cause of digestive dysbiosis leading to intestinal inflammation, digestive permeability and bacterial translocation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Profile 2 | – | Other: Stool sample collection, Other: Blood sample collectionPeople living with HIV with immune activation profile 2: inflammatory profile - high level of sTNFRI |
| Other profiles | – | Other: Stool sample collection, Other: Blood sample collectionPeople living with HIV with immune activation profiles1 + 3-5: T8, NK, T4 and monocyte profiles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men with HIV-1 infection on effective antiretroviral therapy stable for more than 6 months.
Key inclusion criteria (7 listed)
- Patient informed of the implementation of the study, its objectives, its constraints and the patient's rights.
- Male and Caucasian patient.
- Patient with HIV-1 infection determined by positive serology or plasma viral load (HIV RNA) measurement.
- Patient on effective triple antiretroviral therapy, stable for more than 6 months, with a plasma viral load <50 copies / ml for at least 6 months before inclusion (2 measurements).
- Patient whose immune activation profile has been characterized beforehand (profiles 1, 2, 3, 4 and 5).
Key exclusion criteria (9 listed)
- Vulnerable person according to article L1121-6 of the CSP.
- Adult person protected according to article L1121-8 of the CSP.
- Patient presenting with a non-infectious pathology which may be the cause of an immune abnormality.
- Patient having undergone treatment with an immunomodulator molecule or chemotherapy within 60 days before inclusion in the research or has an indication planned for the duration of the research.
- Patient with a chronic digestive pathology or who had been operated on the previous year
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 |
|---|---|---|
| Stool sample collection50mg stool sample taken for protein extraction | Other | Other profiles, Profile 2 |
| Blood sample collectionVenous blood sample taken for analysis of serum and plasma | Other | Other profiles, Profile 2 |
Primary outcome
Nature of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Number of bacterial proteins present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry
Nature of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Number of operational taxonomic units present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry
Relative quantification of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Percentage of the various bacterial proteins present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry (%)
Relative quantification of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Percentage of the various operational taxonomic units present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry (%)
9 secondary outcomes
Richness of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
beta-diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Level of phyla and minority species in the stool in patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Level of CD14S in serum of patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Level of Lipopolysaccharide Binding Protein (LBP) in serum of patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Level of intestinal fatty acid binding protein (I-FABP) in serum of patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Level of bacterial 16S rDNA in plasma of patients with immune activation profile 2 versus all other profiles
Time frame: Day 0
Transcriptomic analysis of peripheral blood mononuclear cells
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
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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.
Jean-Philippe Lavigne study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Nature of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles (time frame: Day 0). 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 13 Feb 2023.