Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients
MICROGUT
Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).
2 other identifiers
observational
80
1 country
4
Brief Summary
The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 16, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 12, 2016
July 1, 2016
1.5 years
April 15, 2014
July 11, 2016
Conditions
Outcome Measures
Primary Outcomes (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.
Baseline
Secondary Outcomes (4)
Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population
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.
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).
Baseline
Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.
Baseline
Study Arms (1)
HIV-1 patients
Interventions
Eligibility Criteria
HIV-1 seropositive patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Centre Henri Mondor
Créteil, 94010, France
Service de Médecine Interne et Immunologie Clinique
Le Kremlin-Bicêtre, 94275, France
IHU Méditerranée Infection; Hôpital Nord, AP-HM
Marseille, 13005, France
Service de maladies Infectieuses
Marseille, 13005, France
Biospecimen
Stool sample
Study Officials
- PRINCIPAL INVESTIGATOR
Didier Raoult, MD
IHU Méditerranée infection
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 16, 2014
Study Start
December 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 12, 2016
Record last verified: 2016-07