| 摘要 |
This invention provides formulations of the anti-HIV therapeutic, CD4-IgG2, that contain higher concentrations of the therapeutic than were previously prepared, are stable, and safe to administer. Methods for making high-concentration CD4-IgG2 formulations by first concentrating CD4-IgG2 to about 50 mg/ml in a buffer comprising about 6.7 mM histidine/2 % maltose, pH 6.0, then lyophilizing the sample and reconstituting it to about 150 mg/ml in a buffer comprising about 20 mM histidine/6 % maltose, pH 6.0, are provided. Such high-concentration CD4-IgG2 formulations are suitable for intravenous, subcutaneous and intramuscular delivery, the latter two routes being potentially useful for facilitating self-administration by HIV-infected individuals. This invention is also directed to methods of using the CD4-IgG2 formulations to inhibit or prevent infect CD4+ cells from becoming infected with HIV, and to treat subjects having CD4+ cells infected with HIV. |
