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.

1 . A method of treating HIV associated diarrhea or highly active antiretroviral therapy (HAART) associated diarrhea in an HIV positive subject, comprising:
 administering about 250 mg of crofelemer to a subject in need thereof.   
     
     
         2 . The method of  claim 1 , wherein treating HIV associated diarrhea or HAART associated diarrhea comprises the subject having a decrease in the number of bowel movements per day, a decrease in the number of watery bowel movements per day, a decrease in the daily abdominal pain or discomfort score, an improvement in the daily stool consistency score, a decrease in the number of days per week that a subject experiences urgency, or a decrease in the number of days per week that a subject experiences fecal incontinence. 
     
     
         3 . The method of  claim 1 , wherein the subject is administered 125 mg crofelemer two times per day. 
     
     
         4 . The method of  claim 1 , wherein the administering comprises from between about 1 month to about 6 months. 
     
     
         5 . The method of  claim 1 , wherein treating results in two or fewer watery bowel movements per week. 
     
     
         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 to 24 weeks. 
     
     
         8 . The method of  claim 1 , wherein the administering comprises about 6 months. 
     
     
         9 . The method of  claim 1 , wherein the administering comprises about 6 months or longer. 
     
     
         10 . The method of  claim 1 , wherein the administering is for the duration of the HIV infection. 
     
     
         11 . The method of  claim 1 , wherein a response to treatment increases after the crofelemer has been administered for longer than 4 months. 
     
     
         12 . The method of  claim 1 , wherein the subject has previously been administered protease inhibitors. 
     
     
         13 . The method of  claim 1 , wherein the crofelemer is isolated from a  Croton  species or a Calophyllum species. 
     
     
         14 . The method of  claim 13 , wherein the crofelemer is isolated from  Croton sakutaris, Croton gossypifolius, Croton palanostima, Croton lechleri, Croton erythrochilus  or  Croton draconoides.    
     
     
         15 . The method of  claim 1 , wherein the crofelemer is enteric coated. 
     
     
         16 . A method of treating highly active antiretroviral 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.   
     
     
         17 . The method of  claim 16 , wherein treating HAART associated diarrhea comprises the subject having a decrease in the number of bowel movements per day, a decrease in the number of watery bowel movements per day, a decrease in the daily abdominal pain or discomfort score, an improvement in the daily stool consistency score, a decrease in the number of days per week that a subject experiences urgency, or a decrease in the number of days per week that a subject experiences fecal incontinence. 
     
     
         18 . The method of  claim 16 , wherein treating results in two or fewer watery bowel movements per week. 
     
     
         19 . The method of  claim 16 , wherein the administering comprises from between about 1 month to about 6 months. 
     
     
         20 . The method of  claim 16 , wherein a response to treatment increases after the crofelemer has been administered for longer than 4 months.