Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection

The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be
safe and effective for inflammatory bowel disease would offer benefit in reducing the
residual immune activation associated with treated HIV-1 infection. Specifically, the two
immediate goals are to examine the safety of Pentasa® in reducing markers of immune
activation believed to be important reflectors of risk for cardiovascular disease and ongoing
immune damage in people with chronic treated HIV-1 infection.

Inclusion Criteria:

- Age at least 18

- On ART for at least 1 year during which: viremia <50 RNA copies/ml for at least 3
measurements (allowing for 1 nonconsecutive blip of <100), and CD4 T cell count
consistently >500 during that time

- CD4 T cell nadir >350

- Last CD4 and T cell test in past 6 months

Exclusion Criteria:

- Plans to modify antiretroviral therapy in the next 12 weeks for any reason

- History of inflammatory bowel disease or irritable bowel disease

- Chronic active hepatitis B or C

- History of autoimmune disease

- Hypersensitivity to any component of Pentasa

- Clostridium difficile infection

- Receiving rectally delivered medications

- Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory
drugs, steroids, or TNF inhibitors)

- Receiving immunosuppressive steroids

- Receiving any medications associated with bleeding risk

- Hemoglobin < 10.0 g/dL

- Platelet count less than 100,000/mm3

- White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3

- Symptoms of sexually transmitted infection

- Antibiotics used in the last 90 days

- Renal insufficiency with creatinine clearance less than 50 ml/min

- Elevated transaminases greater than 2.5 times the upper limit of normal

- Evidence of decompensated cirrhosis, heart failure

- Pregnant or breastfeeding women