Claims for Patent: 9,585,868

Summary for Patent: 9,585,868

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:	NAPO PHARMACEUTICALS, INC. (San Francisco, CA)
Application Number:	14/597,740
Patent Claims:	1. A method of ameliorating symptoms of HIV associated diarrhea or highly active antiretroviral therapy (HAART) associated diarrhea in an HIV positive subject, comprising: administering crofelemer to an HIV positive subject in need thereof in an amount of about 250 mg per day or about 125 mg two times per day to ameliorate the symptoms of HIV associated diarrhea or HAART associated diarrhea in the HIV positive subject. 2. The method of claim 1, wherein the crofelemer is administered for a time period of from about 1 month to about 6 months. 3. The method of claim 1, wherein the crofelemer is administered for a time period of from about 3 days to about 6 months. 4. The method of claim 1, wherein improvement of symptoms begins on day 3. 5. The method of claim 1, wherein improvement of symptoms increases with a longer duration of administration after day 3. 6. The method of claim 1, wherein the crofelemer is administered for at least 8 days. 7. The method of claim 1, wherein the crofelemer is administered from between 8 days and 24 weeks. 8. The method of claim 1, wherein the crofelemer is administered for about 6 months. 9. The method of claim 1, wherein the crofelemer is administered for about 6 months or longer. 10. The method of claim 1, wherein the crofelemer is administered for the duration of the HIV infection. 11. The method of claim 1, wherein the response to treatment increases after the crofelemer has been administered for longer than 4 months. 12. The method of claim 1, wherein the alleviating of symptoms includes 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, stool consistency leading to formed stools from watery stools, 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. 13. The method of claim 12, wherein ameliorating of symptoms includes an improvement in the score for daily stool consistency. 14. The method of claim 12, wherein ameliorating of symptoms includes stool consistency leading to formed stools from watery stools. 15. The method of claim 12, wherein subject is considered treated if the subject demonstrates a decrease in the number of watery bowel movements per day. 16. The method of claim 12, wherein subject is considered treated if the subject demonstrates a decrease in the number of bowel movements per day. 17. The method of claim 12, wherein symptoms increased or decreased are measured from a baseline. 18. The method of claim 1, wherein the alleviating of symptoms includes decreasing the number of days per week a subject experiences fecal incontinence associated with HIV associated diarrhea or HAART associated diarrhea. 19. The method of claim 1, wherein the HIV positive subject is male. 20. A method of treating or improving HIV associated diarrhea or highly active antiretroviral therapy (HAART) associated diarrhea in an HIV positive subject who has previously used protease inhibitors, the method comprising: administering to a subject in need thereof crofelemer in an amount of about 250 mg per day or about 125 mg two times per day to treat or improve HIV associated diarrhea or HAART associated diarrhea in the HIV positive subject who has previously used protease inhibitors.