Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients

HIV-1 Infection Clinical Trial

— MICROGUT  

Official title:

Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116374
• Other study ID #: ANRS EP55 MICROGUT
• Secondary ID: 2014-A00216-41
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: July 11, 2016
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Seropositivity
• HIV-1 Infection

Intervention

Other:
• Physiopathology study

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population		Baseline	No
Secondary	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	No
Secondary	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	No
Secondary	Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.		Baseline	No