Methods for reducing viral load in hiv-1 infected patients

Abstract

This invention provides a method of reducing viral load in an HIV-1-infected human subject which comprises administering to the subject an effective HIV-1 viral load reducing dose of a CCR5 receptor antagonist, such as a humanized antibody designated PRO 140 or an anti-CCR5 receptor monoclonal antibody, wherein the viral load reducing dose achieves an average maximum decrease of viral load in the subject of at least 1.83 log 10 to 2.5 log 10 at about ten days following administration of the CCR5 receptor antagonist and wherein the viral load reducing dose further achieves a mean viral load reduction of 1.7 log 10 at about nine days following administration of the CCR5 receptor antagonist. The viral load reducing dose results in a suppression of mean viral load by 1.0 log 10 within about four days following administration of the CCR5 receptor antagonist, and suppression of viral load in the subject persists at or below a level of reduction of 1.0 log 10 for about two to three weeks. This invention also provides a method of elevating CD4+ cell count in an HIV-1-infected human subject which comprises administering to the subject at a predefined interval an effective HIV-1 viral load-reducing dose of a humanized antibody designated PRO 140, or an anti-CCR5 receptor monoclonal antibody.

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         129 . A CCR5 receptor antagonist formulation consisting of a therapeutically effective dose of a humanized monoclonal antibody designated PRO 140, or a fragment thereof, in an amount of about 2 mg/kg to 25 mg/kg of body weight for a human subject, wherein said PRO 140, or fragment thereof, coats CD4+CCR5+ cells in the subject without reducing the number of such cells in the subject. 
     
     
         130 . A CCR5 receptor antagonist formulation consisting of a therapeutically effective dose of a humanized monoclonal antibody designated PRO 140, or a fragment thereof, in an amount of about 2 mg/kg to 25 mg/kg of body weight for a human subject, wherein said PRO 140, or fragment thereof, binds to the subject's CD4+CCR5+ cells without inducing an increase in the subject's plasma concentration of circulating β-chemokines. 
     
     
         131 . A method of treating a subject comprising administering to the subject a CCR5 receptor antagonist formulation consisting of a therapeutically effective dose of a humanized monoclonal antibody designated PRO 140, or a fragment thereof, in an amount of about 2 mg/kg to 25 mg/kg of body weight for a human subject, wherein said PRO 140, or fragment thereof, coats CD4+CCR5+ cells in the subject without reducing the number of such cells in the subject and/or binds to the subject's CD4+CCR5+ cells without inducing an increase in the subject's plasma concentration of circulating β-chemokines.