CCRC: A Project of the Treatment of HIV Enteropathy With ImmunoLin® Supplements

Inclusion Criteria:

- GI complaints consisting of at least 2 loose or watery stools per day or marked
abdominal bloating that adversely effects activities of daily living (ADLs) or common
social functioning for greater than 6 months, even though the symptomatology may wax
and wane over that time period.

- Subjects should have had routine testing to exclude enteric pathogens.

- Subjects should have made an effort to identify food intolerance, especially lactose
intolerance.

- Symptoms should be believed to be independent of ART or other medications known to
have the potential to cause similar GI complaints; either because the symptoms
predate initiation of the medications or shifts between different options for ART has
had no appreciable effect on symptoms.

- Over the previous 6 months, alcohol use should be characterized as occasional with
less than 1.5 ounces per day being the maximum estimated use (<2 beers or glasses of
wine or 1 drink of hard liquor).

- Subjects will be greater than 18 years of age.

- Plasma HIV load should be suppressed to less than 400 cp/mL for at least four months,
but there is no restriction on peripheral CD4+ T-cell count. Blips of <1000 cp/mL are
allowed, provided that these are not associated with medication interruptions and
that the pVL is undetectable before and after the observed blip.

- Subjects are willing to maintain a food and GI-symptom diary while receiving the
ImmunoLin® supplement.

- Subjects should be willing to attempt to maintain a stable regimen of ART for the
duration of the study unless indicated for patient safety.

- Subjects should be free of antibiotic use for at least 3-weeks prior to study entry
except for chronic antibiotics used for prophylaxis according to SOC in HIV
management. Usage of antibiotics during the course of the study will be assessed on a
case by case basis by the study team.

- Subjects must be free of conditions which require chronic therapy that are known to
alter the gut flora. Steroid use must be limited to intermittent topical preparations
only which includes inhaled or dermatologic routes of application.

Exclusion Criteria:

- known unrelated causes for GI abnormalities.

- abnormal coagulation parameters (PT>1.2 ULN)

- thrombocytopenia (platelet count <50,000 within 6 weeks)

- contra-indications to upper endoscopy or conscious sedation

- anemia (> grade 1 [appendix D])

- aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation
cascade are prohibited within 1 week of endoscopy.

- positive pregnancy test