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

This study has been completed.
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)
ClinicalTrials.gov Identifier:
NCT02116374
First received: April 15, 2014
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.

Condition Intervention
HIV-1 Infection
Other: Physiopathology study

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Stool sample

Enrollment: 80
Study Start Date: December 2014
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV-1 patients Other: Physiopathology study

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: April 15, 2014
Last Updated: July 11, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 23, 2016