Status:
COMPLETED
Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.
Lead Sponsor:
University of Colorado, Denver
Conditions:
HIV
Lipodystrophy
Eligibility:
All Genders
18-65 years
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 compositio...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT02258685
Start Date
November 1 2014
End Date
July 1 2019
Last Update
December 18 2019
Active Locations (1)
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1
University of Colorado Denver
Aurora, Colorado, United States, 80045