Clinical Trial: Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.

Brief Summary: This study plans to learn more about immune responses in intestinal (gut) tissue in people with human immunodeficiency virus (HIV) infection. This study will determine whether change in the composition of gut bacteria in HIV infected individuals is related to a high prevalence of chronic gut inflammation and metabolic disease. The investigators will also investigate immune-modulatory properties of specific bacteria that correlate with disease both by characterizing which functional genes are selected for in their genomes and by stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This work will establish whether gain/loss of bacterial drivers/suppressors of information in the gut contributes to metabolic disease in HIV-infected individuals.

Detailed Summary:

This is a prospective cohort and cross-sectional case-control study. Study participation will last up to 2 months and 93 participants will be enrolled. Participants will be evaluated for lipodystrophy, asked to complete food & gastrointestinal symptoms questionnaires and provide stool samples. A subset of participants will be asked to have a flexible sigmoidoscopy (mucosal biopsy).

Cohort A will consist of 93 participants:

Cohort A1: ART (Antiretroviral therapy) -treated HIV-infected individuals with lipodystrophy (n=35) Cohort A2: ART-treated HIV-infected individuals without lipodystrophy (n=18) Cohort A3: HIV-1 infected individuals naïve to ART (n=20) Cohort A4: HIV-1 seronegative individuals who are at a high risk for infection (n=20)

Cohort B will be a selected subset of subjects from Cohort A:

Cohort B1: ART-treated HIV-infected individuals with HIV-associated dysbiosis (n=10) Cohort B2: ART-treated HIV-infected individuals without HIV-associated dysbiosis (n=10)


Sponsor: University of Colorado, Denver

Current Primary Outcome:

  • Determine the gut microbiota composition using 16S ribosomal RNA (rRNA) sequencing of fecal samples [ Time Frame: 2 months ]
    Compare the gut microbiota composition of HIV-positive subjects with and without lipodystrophy and long-term ART, and HIV-negative controls with diet and metabolic and immune activation markers in blood.
  • Determine of gut microbiota composition using rectosigmoid biopsy tissue [ Time Frame: 2 months ]
    Compare the gut microbiota composition of HIV-positive ART-treated individuals by CD4+ populations and immune activation markers in gut-associated lymphoid tissues (GALT)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Colorado, Denver

Dates:
Date Received: October 1, 2014
Date Started: November 2014
Date Completion: November 2017
Last Updated: December 9, 2016
Last Verified: December 2016