Long Term Treatment of HIV-Infection With TMC278

Abstract

This invention relates to the use of a parenteral formulation comprising an anti-virally effective amount of TMC278 or a pharmaceutically acceptable acid-addition salt thereof, and a carrier, for the manufacture of a medicament for the treatment of a subject being infected with HIV, wherein the formulation is to be administered intermittently at a time interval of at least one week.

1 - 10 . (canceled) 
     
     
         11 . A method of treating HIV in a subject comprising administering to the subject a solution comprising
 an amount of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile (TMC278) or a pharmaceutically acceptable acid-addition salt thereof, and a carrier,   wherein the solution is administered intermittently by subcutaneous or intramuscular administration at a time interval that is once every two months, and   wherein the amount of TMC278, or the pharmaceutically acceptable acid-addition salt thereof, is effective in keeping a minimum blood plasma level of TMC278 in the subject during the time interval.   
     
     
         12 . The method according to  claim 11 , wherein the solution is administered intramuscularly. 
     
     
         13 . The method according to  claim 11 , wherein the minimum blood plasma level is about 5 ng/mL to about 500 ng/mL. 
     
     
         14 . The method according to  claim 11 , wherein the minimum blood plasma level is about 5 ng/mL to about 200 ng/mL. 
     
     
         15 . The method according to  claim 11 , wherein the minimum blood plasma level is about 5 ng/mL to about 100 ng/mL. 
     
     
         16 . The method according to  claim 11 , wherein the minimum blood plasma level is about 10 ng/mL to about 50 ng/mL. 
     
     
         17 . The method according to  claim 11 , wherein the subject's HIV viral load is below about 200 copies/mL, prior to administration of the solution. 
     
     
         18 . The method according to  claim 11 , wherein the solution is an aqueous solution. 
     
     
         19 . The method according to  claim 11 , wherein the time interval is once every two months. 
     
     
         20 . The method according to  claim 11 , wherein the TMC278 is E-TMC278. 
     
     
         21 . The method according to  claim 11 , wherein the carrier comprises polyethyleneglycol. 
     
     
         22 . The method according to  claim 18 , wherein the carrier comprises polyethyleneglycol.