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

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Brief Title

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

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 Description

      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


Primary Outcome

Determine the gut microbiota composition using 16S ribosomal RNA (rRNA) sequencing of fecal samples



Study Arms / Comparison Groups

 Cohort A1
Description:  ART-treated HIV-infected individuals with lipodystrophy


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

November 2014

Completion Date

July 2019

Primary Completion Date

November 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women; 18 years to 65 years (All Cohorts)

          -  Subjects with chronic HIV-1 Infection defined as a positive ELISA confirmed by a
             positive Western Blot or plasma HIV-1 RNA level >1,000 copies/mL at any time in the
             past. (Cohorts A1, A2 & A3)

          -  HIV-1 seronegative (Cohort A4)

          -  Either with or without lipodystrophy (to be assessed at Visit 1)

          -  Body mass index (BMI) between 21-29 mg/kg2 and weight stable for at least 3 months
             (All Cohorts)

          -  Antiretroviral therapy (ART) naïve (Cohort A3): <10 days of ART treatment at any time
             prior to Visit 1 or previously on ART but off treatment for the previous 6 months
             prior to Visit 1

          -  Long-term ART (Cohort A1 & A2): Must be on same antiretroviral treatment and have a
             plasma HIV-1 RNA <25 copies/mL for 3-6 months prior to Visit 1.Liver function tests
             not greater than 2x normal, normal kidney and thyroid function. Fasting glucose must
             be <110 mg/dl

          -  Liver function tests not greater than 2x normal, normal kidney and thyroid function.
             Fasting glucose must be <110 mg/dl

          -  ART-treated individuals whose microbiota resembles those with untreated HIV infection
             and ART-treated individuals whose microbiota resembles the HIV-negative control cohort
             (equal numbers with and without lipodystrophy).(Cohort B; a subset of Cohort A)

        Exclusion Criteria:

          -  Gastrointestinal disease such as inflammatory bowel disease, Clostridium difficile
             colitis or celiac sprue.

          -  history of bowel resection, bleeding disorder, history of hyperglycemia, treated with
             high-dose glucocorticoid therapy or alpha-interferon in past year Current use of
             anticoagulant therapy

          -  Daily use of aspirin or nonsteroidal antiinflammatory drugs (NSAIDs) with inability to
             withhold drug for 7 days before and after a rectosigmoid biopsy procedure.

          -  Used antibiotics within the prior three months

          -  Pregnancy

          -  Current use of proton pump inhibitors and H2-blockers

          -  Active opportunistic or other chronic infection, such as hepatitis B or C or an active

          -  Patient inability to participate in the study, such as inability to undergo
             venipuncture, completion of questionnaire or mucosal biopsy (if selected) procedures
             that form part of the inclusion/exclusion criteria or part of the outcome measure.




18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Catherine Lozupone, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

University of Colorado, Denver

Study Sponsor

Catherine Lozupone, PhD, Principal Investigator, University of Colorado, Denver

Verification Date

December 2019