Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

Inclusion Criteria: * Male or female ≥ 18 years old * History of HIV-1 infection * On an antiretroviral therapeutic regimen for treatment of HIV-1 disease and associated conditions (including prophylactic antibiotics for Pneumocystis jirovecii or infection) for at least 4 weeks prior to screening * Self-reported presence of diarrhea necessitating ADM use for at least 4 weeks Exclusion Criteria: * CD4 counts \< 100 cells/mm3 * Oral temperature greater than 38.0° C, or unintentional weight loss of 5.0 kg or greater during the prior 2 months * Bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin * Immediate need for GI surgery or intervention for active GI bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess