Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

Inclusion Criteria: * History of HIV-1 infection confirmed by standard serological tests * Stable medical regimen for treatment of HIV disease and associated conditions for at least 4 weeks prior to screening * Patient-reported history of diarrhea, defined as either persistently loose stools despite regular ADM use, or one or more watery bowel movements per day without regular ADM use, of at least 1 month duration * Colonoscopy within the past 5 years if ≥ 50 years of age. Exclusion Criteria: * Pregnancy or breast-feeding * Current or past gastrointestinal (GI) medical or surgical conditions * Use of certain opiate pain medication within 2 weeks of screening * Use of an antibiotic within 2 weeks prior to screening, with the exception of stable antibiotic therapy for prophylactic treatment of infection or an HIV-associated condition * CD4 counts \< 100 cells/mm3 * Previous randomization into this study, or into any other crofelemer study