title: Antiretroviral activity of the anti-CD4 monoclonal antibody TNX-355 in patients infected with HIV type 1.
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.
authors.affiliation: Division of Infectious Diseases, University of Colorado Health Sciences Center, Denver, USA. dkuritzkes@partners.org
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Kuritzkes
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Jacobson
authors.forename: William G
authors.initials: WG
authors.lastname: Powderly
authors.forename: Eliot
authors.initials: E
authors.lastname: Godofsky
authors.forename: Edwin
authors.initials: E
authors.lastname: DeJesus
authors.forename: Frances
authors.initials: F
authors.lastname: Haas
authors.forename: Keith A
authors.initials: KA
authors.lastname: Reimann
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Larson
authors.forename: Patrice O
authors.initials: PO
authors.lastname: Yarbough
authors.forename: Valentin
authors.initials: V
authors.lastname: Curt
authors.forename: William R
authors.initials: WR
authors.lastname: Shanahan
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000276:immunology / Q000628:therapy* / Q000821:virology; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D015704:CD4 Antigens / Q000276:immunology*; D018791:CD4 Lymphocyte Count; D005260:Female; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood
chemical_list: D019380:Anti-HIV Agents; D000911:Antibodies, Monoclonal; D015704:CD4 Antigens; D012367:RNA, Viral