Pharmaceutical Compositions - 2

Abstract

The invention provides compositions comprising formula 1 steroids, e.g., 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate and one or more excipients, typically wherein the composition comprises less than about 3% water. The compositions are useful to make improved pharmaceutical formulations. The invention also provides methods of intermittent dosing of steroid compounds such as analogs of 16α-bromo-3β-hydroxy-5α-androstan-17-one and compositions useful in such dosing regimens. The invention further provides compositions and methods to inhibit pathogen (viral) replication, ameliorate symptoms associated with immune dysregulation and to modulate immune responses in a subject using certain steroids and steroid analogs. The invention also provides methods to make and use these immunomodulatory compositions and formulations.

1 - 12 . (canceled) 
     
     
         13 : A method to treat or ameliorate a  Mycobacterium  infection in a mammal, comprising administration of an effective amount of a compound to the mammal wherein the mammal is a human and the compound is 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate or 16α-bromo-3β-hydroxy-5α-androstan-17-one. 
     
     
         14 : The method of  claim 13  wherein the  Mycobacterium  infection is a  Mycobacterium tuberculosis  infection. 
     
     
         15 : The method of  claim 14  wherein the administration is by intermittent dosing. 
     
     
         16 . The method of  claim 14  wherein the compound is 16α-bromo-3β-hydroxy-5α-androstan-17-one. 
     
     
         17 : The method of  claim 16  wherein the human has an HIV infection. 
     
     
         18 : The method of  claim 14  wherein the compound is 16α-bromo-3β-hydroxy-5α-androstan-17-one hemihydrate. 
     
     
         19 : The method of  claim 18  wherein the human has an HIV infection.