Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.
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|ClinicalTrials.gov Identifier: NCT02258685|
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : December 18, 2019
|Condition or disease|
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)
|Study Type :||Observational|
|Actual Enrollment :||93 participants|
|Official Title:||Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 2018|
|Actual Study Completion Date :||July 2019|
ART-treated HIV-infected individuals with lipodystrophy
ART-treated HIV-infected individuals without lipodystrophy
HIV-1 infected individuals naïve to ART
HIV-1 seronegative individuals who are at a high risk for infection
A subset of subjects from Cohort A: ART-treated HIV-infected individuals with HIV-associated dysbiosis
A subset of subjects from Cohort A: ART-treated HIV-infected individuals without HIV-associated dysbiosis
- 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)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02258685
|United States, Colorado|
|University of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Catherine Lozupone, PhD||University of Colorado, Denver|