Drug combination for the treatment of viral diseases

Abstract

This invention pertains to a method for treating a human with human immunodeficiency virus infection which comprises administering to the human a therapeutically effective amount of a thymidine analog, which analog acts as an inhibitor of viral reverse transcriptase necessary for viral replication of human immunodeficiency virus, and a thymidylate synthase inhibitor, or pharmaceutically acceptable salts thereof.

We claim:  
     
         1 . A method for treating a human with human immunodeficiency virus infection which comprises administering to the human a therapeutically effective amount of a thymidine analog, which analog acts as an inhibitor of viral reverse transcriptase necessary for viral replication of human immunodeficiency virus, and a thymidylate synthase inhibitor, or pharmaceutically acceptable salts thereof.  
     
     
         2 . The method according to  claim 1 , wherein the thymidine analog is selected from the group consisting of 3′-azido-3′-deoxythymidine, and D4T.  
     
     
         3 . The method according to  claim 2 , wherein the thymidine analog is 3′-azido-3′-deoxythymidine.  
     
     
         4 . The method according to  claim 1 , wherein the thymidylate synthase inhibitor is selected from the group consisting of 5-fluorouracil, 5-fluoro-2-pyrimidone, and floxuridine.  
     
     
         5 . The method according to  claim 4 , wherein the thymidylate synthase inhibitor is floxuridine.  
     
     
         6 . The method according to  claim 1 , further comprising a therapeutically effective amount of a folate antagonist, or a pharmaceutically acceptable salt thereof.  
     
     
         7 . The method according to  claim 1 , wherein the folate antagonist is selected from the group consisting of methotrexate and trimetraexate.  
     
     
         8 . The method according to  claim 1 , wherein the folate antagonist is methotrexate.  
     
     
         9 . The method according to  claim 1 , further comprising a therapeutically effective amount of hydroxyurea, or a pharmaceutically acceptable salt thereof.  
     
     
         10 . The method according to  claim 1 , wherein the thymidine analog is administered in an amount from about 5 mg to 250 mg per kilogram body weight per day.  
     
     
         11 . The method according to  claim 10 , wherein the thymidine analog is administered in an amount from about 7.5 mg to 100 mg per kilogram body weight per day.  
     
     
         12 . The method according to  claim 1 , wherein the thymidylate synthase inhibitor is administered in an amount from about 0.01 mg to 25 mg per kilogram body weight per day.  
     
     
         13 . The method according to  claim 12 , wherein the thymidylate synthase inhibitor is administered in an amount from about 0.01 mg to 10 mg per kilogram body weight per day.  
     
     
         14 . The method according to  claim 1 , wherein the folate antagonist is administered in an amount from about 0.05 mg to 25 mg per kilogram body weight per day.  
     
     
         15 . The method according to  claim 14 , wherein the folate antagonist is administered in an amount from about 0.05 mg to 10 mg per kilogram body weight per day.  
     
     
         16 . The method according to  claim 1 , wherein hydroxyurea is administered in an amount from about 5 mg to 250 mg per kilogram body weight per day.  
     
     
         17 . The method according to  claim 16 , wherein hydroxyurea is administered in an amount from about 7.5 mg to 100 mgper kilogram body weight per day.