Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT02116374
• Date of registration: 15/04/2014
• Prospective Registration: Yes
• Primary sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Public title: Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients MICROGUT
• Scientific title: Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).
• Date of first enrolment: December 2014
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02116374
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Didier Raoult, MD
• Affiliation: IHU Méditerranée infection

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV-1 Infection

Intervention(s)

Other: Physiopathology study

Primary Outcome(s)

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(s)

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]

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]

Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg. [Time Frame: Baseline]

Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population [Time Frame: Baseline]

Secondary ID(s)

2014-A00216-41

ANRS EP55 MICROGUT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors