HIV-1 InfectionMICROGUTNCT02116374
Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients
An observational study of HIV-1 Infection, run by ANRS, Emerging Infectious Diseases at 4 sites in France.
Trial summary
The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Physiopathology study
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2014to Jun 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-1 seropositive patients
Who may be able to join
- Patient aged 18 or more.
- Patients with a confirmed diagnosis of HIV infection 1.
- Patient who signed an informed consent form.
- Patient affiliated or beneficiary of a social security system.
Who cannot join
- Patient known to be suffering from inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Patient HIV-2 or HIV-1/HIV-2 co-infected
- Patient having received immunotherapy
- Patient participating in another research.
- Pregnant women, parturient or lactating person under guardianship, or deprived of liberty by a judicial or administrative decision.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Henri Mondor
Créteil, 94010
Service de Médecine Interne et Immunologie Clinique
Le Kremlin-Bicêtre, 94275
IHU Méditerranée Infection; Hôpital Nord, AP-HM
Marseille, 13005
Service de maladies Infectieuses
Marseille, 13005
About this study
Official title: Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).
The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.
- Conditions
- HIV-1 Infection
- Being tested
- Physiopathology study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiopathology studyOther
| Study group | Role | What they receive |
|---|---|---|
| HIV-1 patients | Not described Receives: Other: Physiopathology study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion and type of OTU (Operational Taxonomic Unit) assigned to the rank of phylum genus and species of bacteria in the intestinal microbiota of HIV-1 seropositive patients.
Measured: Baseline
Secondary outcomes (4)
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population
Measured: Baseline
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on CD4, viral load, the Elite controller status, antiretroviral and antibiotic treatment and the existence of invasive bacterial infections.
Measured: Baseline
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on inflammation parameters (IL-6, TNF-a, IP-10), CRPus, CD14 and integrity of the epithelial barrier (I-FABP).
Measured: Baseline
Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Didier Raoult, MD, Principal investigator, IHU Méditerranée infection
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116374
- Sponsor's protocol ID
- ANRS EP55 MICROGUT
- Other IDs
- 2014-A00216-41
- Acronym
- MICROGUT
- Status last verified
- Jul 2016
- First submitted
- 15 Apr 2014
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).
- ClinicalTrials.gov ID
- NCT02116374
- Acronym / sponsor ID
- MICROGUT / ANRS EP55 MICROGUT
- Conditions
- HIV-1 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-1 patients | – | Other: Physiopathology study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 seropositive patients
Key inclusion criteria (4 listed)
- Patient aged 18 or more.
- Patients with a confirmed diagnosis of HIV infection 1.
- Patient who signed an informed consent form.
- Patient affiliated or beneficiary of a social security system.
Key exclusion criteria (5 listed)
- Patient known to be suffering from inflammatory bowel disease (Crohn's disease or ulcerative colitis).
- Patient HIV-2 or HIV-1/HIV-2 co-infected
- Patient having received immunotherapy
- Patient participating in another research.
- Pregnant women, parturient or lactating person under guardianship, or deprived of liberty by a judicial or administrative decision.
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 |
|---|---|---|
| Physiopathology study | Other | HIV-1 patients |
Primary outcome
Proportion and type of OTU (Operational Taxonomic Unit) assigned to the rank of phylum genus and species of bacteria in the intestinal microbiota of HIV-1 seropositive patients.
Time frame: Baseline
4 secondary outcomes
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population
Time frame: Baseline
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on CD4, viral load, the Elite controller status, antiretroviral and antibiotic treatment and the existence of invasive bacterial infections.
Time frame: Baseline
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on inflammation parameters (IL-6, TNF-a, IP-10), CRPus, CD14 and integrity of the epithelial barrier (I-FABP).
Time frame: Baseline
Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
Related trials for HIV-1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
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.
Didier Raoult, MD principal investigator
IHU Méditerranée infection
4 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-1 Infection, run by ANRS, Emerging Infectious Diseases at 4 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion and type of OTU (Operational Taxonomic Unit) assigned to the rank of phylum genus and species of bacteria in the intestinal microbiota of HIV-1 seropositive patients. (time frame: Baseline). 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 12 Jul 2016.