Antiretroviral Activity of the Anti-CD4 Monoclonal Antibody TNX-355 in Patients Infected with HIV Type 1

Daniel R. Kuritzkes, Jeffrey Jacobson, William G. Powderly, Eliot Godofsky, Edwin DeJesus, Frances Haas, Keith A. Reimann, Jeffrey L. Larson, Patrice O. Yarbough, Valentin Curt, William R. Shanahan

Research output: Contribution to journalArticlepeer-review

180 Scopus citations


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.

Original languageEnglish
Pages (from-to)286-291
Number of pages6
JournalJournal of Infectious Diseases
Issue number2
StatePublished - Jan 15 2004


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