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

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ClinicalTrials.gov Identifier: NCT02116374
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief Summary:
The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.

Condition or disease Intervention/treatment
HIV-1 Infection Other: Physiopathology study

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).
Study Start Date : December 2014
Primary Completion Date : June 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population [ Time Frame: Baseline ]
  2. 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 ]
  3. 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 ]
  4. Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg. [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Stool sample


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1 seropositive patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116374


Locations
France
Centre Henri Mondor
Creteil, France, 94010
Service de Médecine Interne et Immunologie Clinique
Le Kremlin Bicêtre, France, 94275
IHU Méditerranée Infection; Hôpital Nord, AP-HM
Marseille, France, 13005
Service de maladies Infectieuses
Marseille, France, 13005
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: Didier Raoult, MD IHU Méditerranée infection

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02116374     History of Changes
Other Study ID Numbers: ANRS EP55 MICROGUT
2014-A00216-41 ( Other Identifier: ANSM )
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases