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1. WO2012058664 - METHODS AND COMPOSITIONS FOR TREATING HIV-ASSOCIATED DIARRHEA

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[ EN ]

119557-06020

What is claimed is:

1. A method of treating HIV associated diarrhea or highly active antiretro viral therapy (HAART) associated diarrhea in an HIV positive subject, comprising:

administering about 250 mg to about 1000 mg per day; administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day;

administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a subject in need thereof.

2. A method of treating stool consistency in an HIV positive subject, comprising: administering about 250 mg to about 1000 mg per day; administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day;

administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a subject in need thereof.

3. A method of improving stool consistency in an HIV positive subject, comprising: administering about 250 mg to about 1000 mg per day; administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day;

administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a subject in need thereof.

4. A method of alleviating watery diarrhea in an HIV positive subject, comprising: administering about 250 mg to about 1000 mg per day; administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day;

administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a subject in need thereof.

5. A method of decreasing the number of bowel movements per day in an HIV positive Attorney Docket No. 119557-06005 subject, comprising:

administering about 250 mg to about 1000 mg per day; administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day;

administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a subject in need thereof.

6. The method of any one of claims 1 - 5, wherein the administering is from between about 1 month and about 6 months.

7. The method of any one of claims 1 - 5, wherein the administering is from between about 3 days and 6 months.

8. The method of any one of claims 1 - 5, wherein improvement of symptoms begins on day 3.

9. The method of any one of claims 1 - 5, wherein improvement of symptoms increases with a longer duration of administration after day 3.

10. The method of any one of claims 1 - 5, wherein the subject is of Caucasian or Hispanic descent.

11. The method of any one of claims 1 - 5, wherein the crofelemer is administered for at least 8 days.

12. The method of any one of claims 1 - 5, wherein the crofelemer is administered from between 8 days and 24 weeks.

13. The method of any one of claims 1 - 5, wherein the administering is for about 6 months.

Attorney Docket No. 119557-06005

14. The method of any one of claims 1 - 5, wherein the administering is about 6 months or longer.

15. The method of any one of claims 1 - 5, wherein the administering is for the duration of the HIV infection.

16. The method of any one of claims 1 - 5, 12 and 15, wherein the response to treatment increases after the crofelemer has been administered for longer than 4 months.

17. The method of claim 1, wherein a 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, a 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.

18. The method of claim 2, wherein subject is considered treated if the subject demonstrates an improvement in the score for daily stool consistency.

19. The method of claim 3, wherein subject is considered treated if the subject demonstrates a decrease in stool consistency.

20. The method of claim 4, wherein subject is considered treated if the subject demonstrates a decrease in the number of watery bowel movements per day.

21. The method of claim 5, wherein subject is considered treated if the subject demonstrates a decrease in the number of bowel movements per day.

22. The method of any one of claims 17 - 21, wherein symptoms increased or decreased are measured from a baseline.

Attorney Docket No. 119557-06005

23. 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 to about 1000 mg per day; administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day; administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a subject experiencing fecal incontinence associated with HIV or HAART.

24, A method of treating HIV associated diarrhea or highly active antiretro viral therapy (HAART) associated diarrhea in a male HIV positive subject, comprising: administering about 250 mg to about 1000 mg per day; administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day; administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a male subject in need thereof.

25. A method of treating HIV associated diarrhea or highly active antiretro viral therapy (HAART) associated diarrhea in an HIV positive subject that has previously used protease inhibitors, comprising: administering about 250 mg to about 1000 mg per day;

administering about 250 mg per day; administering about 500 mg per day; administering about 1000 mg per day; administering about 125 mg two times per day; administering about 250 mg two times per day; or administering about 500 mg two times per day of crofelemer to a male subject who has previously used protease inhibitors.

26. A method of treating abnormal stool consistency associated with d-IBS comprising, administering 125 mg crofelemer two times per day for at least one month to a subject.

27. The method of claim 26, wherein crofelemer is administered between one month and two months.

28. The method of claim 26, wherein crofelemer is administered between from between about one month and about three months or longer.

Attorney Docket No. 119557-06005

29. The method of any one of claims 26, wherein the subject is a female.

30. A method of treating abdominal pain associated with d-IBS comprising

administering 125 mg crofelemer two times per day for at least one month to a subject.

31. The method of claim 30, wherein crofelemer is administered between one month and two months.

32. The method of claim 30, wherein crofelemer is administered between from between about one month and about three months or longer.

33. The method of any one of claims 30, wherein the subject is a female.