Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

This study is evaluating the effectiveness of the oral nutritional therapy serum-derived
bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6
months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects
with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory
intestinal microbial populations, bacterial translocation, intestinal barrier function, and
systemic immune activation will be investigated.

Inclusion Criteria:

- History of HIV-1 infection

- Plasma HIV viral load ≤40 copies/mL

- Maintained virologic suppression for 1 year

- Stable Antiretroviral Therapy (ART) regimen

- History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed
stools per day or a liquid stool volume greater than 200 g per day for at least 4
weeks duration

Exclusion Criteria:

- Positive stool test for pathogenic bacteria, C. difficile or ova and parasites

- Conditions that require chronic therapy that is known to alter gut microbiota

- Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)