Impact of SBI, a Medical Food, on Nutritional Status in Patients With HIV-associated Enteropathy

Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Study Evaluating the Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in HIV+ Subjects With HIV-associated Enteropathy.

The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects 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)