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Completed

NCT Number: NCT02116374

Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients

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

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Henri Mondor, Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiopathology study

Other

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.

    Time frame: Baseline

Secondary outcomes

  1. Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population

    Time frame: Baseline

  2. 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

  3. 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

  4. Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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

Acronym: MICROGUT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2014
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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