Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients

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.

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.