Aurora, Colorado 80045


Purpose:

The primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States.


Study summary:

This is a randomized clinical trial. Fifty (50) Antiretroviral therapy (ART)-treated Human immunodeficiency virus (HIV) positive participants, 24 HIV negative controls matched for age and sex, and 24 HIV negative controls from a population at high risk for contracting HIV will be recruited into 3 cohorts. All participants will undergo a 4 week diet modification and will be randomly assigned to receive either an Agrarian diet or a Western-type diet. For the first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks where participants will be provided a diet menu with recipes to prepare themselves. There will be 4 study visits and participation will last for up to 2 months.


Criteria:

Inclusion Criteria: - HIV-infected cohort (Cohort A) - Documentation of HIV-1 infection defined as a positive antibody test or plasma HIV-1 RNA (ribosomal ribonucleic acid). - Treated with ART (minimum of three antiretroviral drugs in regimen) for at least 12 months with no changes in antiretroviral drugs over the past 6 months - Plasma HIV-1 RNA ≤ 50 copies/mL in the preceding 6 months. - HIV-negative cohorts (Cohort B and C) - Documentation of a negative HIV-1 antibody test - All Cohorts - Age 18 to 65 years - Body mass index between 21-29 kg/m2 (non-obese) - Stable weight for at least 3 months (≤15% change in body weight) - Negative pregnancy test (if female) Exclusion Criteria: - Use of systemic (oral or parenteral) antibiotics within two months prior to study entry - Active chronic infection such as hepatitis B or C or an active malignancy that requires systemic chemotherapy.


NCT ID:

NCT02610374


Primary Contact:

Principal Investigator
Catherine Lozupone, PhD
University of Colorado, Denver

Catherine Lozupone, PhD
Phone: 303-724-7942
Email: catherine.lozupone@ucdenver.edu


Backup Contact:

N/A


Location Contact:

Aurora, Colorado 80045
United States

Catherine Lozupone, PhD
Phone: 303-724-7942
Email: catherine.lozapone@ucdenver.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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