Substitution monotherapy treatment for hiv-1 infection employing antibody pro140

Abstract

This invention relates to the use of antibody therapy as a treatment substitute, or for treatment interruption, to treat HIV-1 infected patients. Specifically, the present invention relates to the use of antibody therapy, such as PRO 140 monoclonal antibody therapy, as a monotherapy for treatment of HIV-1 infected patients.

1 . A method for treating an HIV-1 infected subject comprising:
 administering PRO 140 or a fragment thereof as a treatment substitution monotherapy; and   preventing virologic failure for a time period greater than four weeks.   
     
     
         2 . (canceled) 
     
     
         3 . he method of  claim 1 , wherein the HIV-1 infected subject is stable on combination antiretroviral therapy prior to initiation of the treatment substitution monotherapy. 
     
     
         4 . (canceled) 
     
     
         5 . The method of  claim 1 , wherein PRO 140 or a fragment thereof is administered either intravenously or subcutaneously. 
     
     
         6 . The method of  claim 1 , wherein PRO 140 or a fragment thereof is administered subcutaneously in an amount of about 324 mg, 350mg, 5 mg/kg, or 10 mg/kg. 
     
     
         7 . The method of  claim 1 , wherein PRO 140 or a fragment thereof is administered subcutaneously at a concentration of 175 mg/mL. 
     
     
         8 . The method of  claim 1 , comprising administering PRO 140 or a fragment thereof one of once per week, once every two weeks, and once a month. 
     
     
         9 . The method of  claim 1 , wherein the HIV-1 infected subject receives PRO 140 or a fragment thereof for a period of one of one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, and one year. 
     
     
         10 . The method of  claim 1 , wherein the HIV-1 infected subject receives PRO 140 or a fragment thereof for a period of at least one year. 
     
     
         11 . The method of  claim 1 , wherein the HIV-1 infected subject returns to combination antiretroviral therapy following PRO 140 or a fragment thereof monotherapy. 
     
     
         12 . The method of  claim 1 , further comprising providing the HIV-1 infected subject with at least about a 60% likelihood of virologic failure for a time period greater than four weeks. 
     
     
         13 . A method for improving drug regime adherence by providing an HIV-1 infected subject with a treatment comprising:
 administering PRO 140 or a fragment thereof as a treatment substitution monotherapy; and   preventing virologic failure for a time period greater than four weeks.   
     
     
         14 . (canceled) 
     
     
         15 . The method for improving drug regime adherence of  claim 13 , comprising administering PRO 140 or a fragment thereof one of once per week, once every two weeks, and once a month. 
     
     
         16 . The method for improving drug regime adherence of  claim 13 , wherein the HIV-1 infected subject receives PRO 140 or a fragment thereof for a period of one of one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, and one year. 
     
     
         17 . The method for improving drug regime adherence of  claim 13 , wherein PRO 140 or a fragment thereof is self-administered subcutaneously in an amount of about 324 mg, 350 mg, 5 mg/kg, or 10 mg/kg. 
     
     
         18 . A method for treating an HIV-1 infected subject with a treatment comprising:
 providing PRO 140 or a fragment thereof in a self-administrable dosage form;   administering the PRO 140 or a fragment thereof as a treatment substitution monotherapy; and   preventing virologic failure for a time period greater than four weeks.   
     
     
         19 . (canceled) 
     
     
         20 . The method for treating an HIV-1 infected subject of  claim 18 , further comprising testing the HIV-1 infected subject for virologic failure and resuming treatment with other anti-HIV drugs in the event of virologic failure.