Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients (MICROGUT)

July 11, 2016 updated by: ANRS, Emerging Infectious Diseases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Centre Henri Mondor
      • Le Kremlin Bicêtre, France, 94275
        • Service de médecine interne et immunologie clinique
      • Marseille, France, 13005
        • IHU Méditerranée Infection; Hôpital Nord, AP-HM
      • Marseille, France, 13005
        • Service de maladies Infectieuses

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV-1 seropositive patients

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV-1 patients
Other: Physiopathology study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population
Time Frame: Baseline
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
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
Baseline
Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Didier Raoult, MD, IHU Méditerranée infection

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS EP55 MICROGUT
  • 2014-A00216-41 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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