Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients

Completed

• Conditions: HIV-1 Infection

• Registration Number: NCT02116374
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Study Start: 2014-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.	Baseline
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 inflammation parameters (IL-6, TNF-a, IP-10), CRPus, CD14 and integrity of the epithelial barrier (I-FABP).	Baseline

Trial Locations

Locations (4)

Centre Henri Mondor; 🇫🇷 Creteil, France

Service de Médecine Interne et Immunologie Clinique; 🇫🇷 Le Kremlin Bicêtre, France

IHU Méditerranée Infection; Hôpital Nord, AP-HM; 🇫🇷 Marseille, France

Service de maladies Infectieuses; 🇫🇷 Marseille, France