Claims for Patent: 8,962,680

Summary for Patent: 8,962,680

Title:	Methods and compositions for treating HIV-associated diarrhea
Abstract:	Presented herein are methods for treating diarrhea by administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea. Treatment of diarrhea includes the treatment of the diarrhea as well as the pain, abdominal discomfort and other symptoms associated with diarrhea. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.
Inventor(s):	Forbes; William (Raleigh, NC), Bortey; Enoch (Chapel Hill, NC), King; Steven (Moss Beach, CA), Chaturvedi; Pravin (Andover, MA)
Assignee:	Salix Pharmaceuticals, Ltd. (Raleigh, NC) Napo Pharmaceuticals, Inc. (San Francisco, CA)
Application Number:	13/285,397
Patent Claims:	1. A method of treating stool consistency in an HIV positive subject, comprising: administering about 250 mg of crofelemer per day to the HIV positive subject. 2. A method of improving stool consistency in an HIV positive subject, comprising: administering about 250 mg of crofelemer per day to the HIV positive subject. 3. A method of alleviating watery diarrhea in an HIV positive subject, comprising: administering about 250 mg of crofelemer per day to the HIV positive subject. 4. A method of decreasing the number of bowel movements per day in an HIV positive subject, comprising: administering about 250 mg of crofelemer per day to the HIV positive subject. 5. The method of any one of claim 1, 2, 3 or 4 wherein the administering is from between about 1 month and about 6 months. 6. The method of any one of claim 1, 2, 3 or 4 wherein the administering is from between about 3 days and 6 months. 7. The method of any one of claim 1, 2, 3 or 4 wherein improvement of symptoms begins on day 3. 8. The method of any one of claim 1, 2, 3 or 4 wherein improvement of symptoms increases with a longer duration of administration after day 3. 9. The method of any one of claim 1, 2, 3 or 4 wherein the subject is of Caucasian or Hispanic descent. 10. The method of any one of claim 1, 2, 3 or 4 wherein the crofelemer is administered for at least 8 days. 11. The method of any one of claim 1, 2, 3 or 4 wherein the crofelemer is administered from between 8 days and 24 weeks. 12. The method of any one of claim 1, 2, 3 or 4 wherein the administering is for about 6 months. 13. The method of any one of claim 1, 2, 3 or 4 wherein the administering is about 6 months or longer. 14. The method of any one of claim 1, 2, 3 or 4 wherein the administering is for the duration of the HIV infection. 15. The method of any one of claim 1, 2, 3 or 4 wherein the response to treatment increases after the crofelemer has been administered for longer than 4 months. 16. The method of any one of claim 1, 2, 3 or 4 wherein the subject is considered treated if the subject demonstrates one or more of: a decrease in the number of bowel movements per day, a decrease in the number of watery bowel movements per day, an improvement in the daily abdominal score for pain or discomfort, an improvement in the score for daily stool consistency, a decrease in stool consistency, a decrease in the number of days per week that subjects experienced urgency, a decrease in the number of days per week that subjects experienced fecal incontinence, or a decrease in the unscheduled visit for a significant worsening of diarrhea. 17. The method of claim 1, wherein subject is considered treated if the subject demonstrates an improvement in the score for daily stool consistency. 18. The method of claim 2, wherein subject is considered treated if the subject demonstrates a decrease in stool consistency. 19. The method of claim 3, wherein subject is considered treated if the subject demonstrates a decrease in the number of watery bowel movements per day. 20. The method of claim 4, wherein subject is considered treated if the subject demonstrates a decrease in the number of bowel movements per day. 21. The method of claim 16, wherein symptoms increased or decreased are measured from a baseline. 22. A method of decreasing the number of days per week a subject experiences fecal incontinence associated with HIV associated diarrhea or HAART associated diarrhea, comprising: administering about 250 mg of crofelemer per day to the subject experiencing fecal incontinence associated with HIV or HAART. 23. The method of claim 1, comprising administering about 125 mg of crofelemer to the subject two times per day. 24. The method of claim 2, comprising administering about 125 mg of crofelemer to the subject two times per day. 25. The method of claim 3, comprising administering about 125 mg of crofelemer to the subject two times per day. 26. The method of claim 4, comprising administering about 125 mg of crofelemer to the subject two times per day. 27. The method of claim 22, comprising administering about 125 mg of crofelemer to the subject two times per day.