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

Completed

Conditions studied: HIV, Lipodystrophy

In brief

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.

Key facts

Study ID

NCT02258685

Run by

University of Colorado, Denver

People needed

93

Starts

2014-11-01

Expected to finish

2019-07-01

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 malignancy
• 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.

Where it is running

• University of Colorado Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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