Antiretroviral activity of the anti-CD4 monoclonal antibody TNX-355 in patients infected with HIV type 1 |
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Authors: | Kuritzkes Daniel R Jacobson Jeffrey Powderly William G Godofsky Eliot DeJesus Edwin Haas Frances Reimann Keith A Larson Jeffrey L Yarbough Patrice O Curt Valentin Shanahan William R |
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Affiliation: | Division of Infectious Diseases, University of Colorado Health Sciences Center, Denver, USA. dkuritzkes@partners.org |
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Abstract: | BACKGROUND: We wished to determine the safety and anti-human immunodeficiency virus (HIV) type 1 activity of single doses of TNX-355, a humanized IgG4 anti-CD4 monoclonal antibody with potent activity against HIV-1 in vitro, in HIV-infected subjects. METHODS: Sequential cohorts of 6 HIV-1-infected subjects each received infusions of TNX-355. Data included plasma HIV-1 RNA level, CD4+ T cell count, TNX-355 coating of CD4+ T cells, and serum TNX-355 levels. RESULTS: Dose-related reductions in plasma HIV-1 RNA loads correlated with complete CD4+ T cell coating by TNX-355. Peak median decreases in plasma HIV-1 RNA loads were 0.56, 1.33, and 1.11 log10 copies/mL and occurred on days 4-7, 14, and 21 for the 3.0, 10, and 25 mg/kg doses, respectively. Dose-dependent increases in CD4+ T cell count occurred within 24 h of dosing. CONCLUSIONS: Single doses of TNX-355 reduced plasma HIV-1 RNA loads and increased CD4+ T cell counts in HIV-infected subjects. The further assessment of therapeutic potential awaits data from longer-duration trials. |
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