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Claims for Patent: 8,633,219

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Claims for Patent: 8,633,219

Title:Combination therapy
Abstract: The present invention relates to a combination therapy for treating an HIV infection or inhibiting integrase comprising (S)-6-(3-Chloro-2-fluorobenzyl)-1-(1-hydroxymethyl-2-methylpropyl)-7-meth- oxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid ("Compound A") or a pharmaceutically acceptable solvate or salt thereof in combination with at least one other anti-HIV agent. In some embodiments of the present invention, the other anti-HIV agents are chosen from reverse transcriptase inhibitors and protease inhibitors. In certain embodiments of the present invention, the other anti-HIV agents are chosen from AZT, 3TC, PMPA, efavirenz, indinavir, nelfinavir, a combination of AZT/3TC, and a combination of PMPA/3TC. Since Compound A has a high inhibitory activity specific for integrases, when used in combinations with other anti-HIV agents it can provide a combination therapy with fewer side effects for humans.
Inventor(s): Matsuzaki; Yuji (Osaka, JP), Watanabe; Wataru (Osaka, JP), Ikeda; Satoru (Osaka, JP), Kano; Mitsuki (Osaka, JP)
Assignee: Japan Tobacco Inc. (Tokyo, JP)
Application Number:11/133,463
Patent Claims: 1. A method for treating an HIV infectious disease in a human patient comprising administering to the patient a combination of: (a) an effective amount of (S)-6-(3-Chloro-2-fluorobenzyl)-1-(1-hydroxymethyl-2-methylpropyl)-7-meth- oxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable solvate or salt thereof, (b) an effective amount of tenofovir disoproxil fumarate, and (c) an effective amount of emtricitabine.

2. The method of claim 1, wherein (a) and (b) and (c) are formulated together and administered as a single therapeutic composition.

3. A method for treating an HIV infectious disease in a human patient comprising administering to the patient a combination of: (a) an effective amount of (S)-6-(3-Chloro-2-fluorobenzyl)-1-(1-hydroxymethyl-2-methylpropyl)-7-meth- oxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable solvate or salt thereof, (b) an effective amount of GS-7340, and (c) an effective amount of emtricitabine.

4. The method of claim 3, wherein (a) and (b) and (c) are formulated together and administered as a single therapeutic composition.

5. A composition for treating an HIV infectious disease in a human patient comprising: (a) an effective amount of (S)-6-(3-Chloro-2-fluorobenzyl)-1-(1-hydroxymethyl-2-methylpropyl)-7-meth- oxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable solvate or salt thereof, (b) an effective amount of tenofovir disoproxil fumarate, and (c) an effective amount of emtricitabine.

6. A composition for treating an HIV infectious disease in a human patient comprising: (a) an effective amount of (S)-6-(3-Chloro-2-fluorobenzyl)-1-(1-hydroxymethyl-2-methylpropyl)-7-meth- oxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid or a pharmaceutically acceptable solvate or salt thereof, (b) an effective amount of GS-7340, and (c) an effective amount of emtricitabine.
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