title: A phase I study of a six-week cycle of immunotherapy with Murabutide in HIV-1 patients naive to antiretrovirals.
abstract: BACKGROUND
  Limitations in the use of antiretroviral therapy suggest the need for additional approaches to enhance immune restoration and the control of HIV-1 replication. Therefore, we evaluated the clinical tolerance and biological effects of immunotherapy with the synthetic immunomodulator Murabutide in 9 treatment-naive HIV-1 patients presenting with CD4+ lymphocyte counts >500 cells/mm3 and plasma viral loads <30.000 copies/ml.
  
  
  METHODS
  Murabutide was administered at a daily dose of 7 mg on 5 consecutive days per week, for a period of 6 weeks. The study duration extended over 22 weeks, and clinical, virological, and immunological evaluations were carried out on 2 occasions before, during, and after immunotherapy.
  
  
  RESULTS
  With acceptable clinical tolerance and only 2 reversible grade III adverse events, clinical and virological parameters remained highly stable throughout the study period. However, maintained or improved lymphoproliferative responses to several recall and HIV-1 antigens, as well as modest but significant increases in the percentages of naive cells were noted during or/and after immunotherapy. These changes could not be demonstrated in an observation group of 9 additional patients who were identically followed for a 22-week period.
  
  
  CONCLUSIONS
  Our results suggest that non-specific immunotherapy targeting dysfunctions in innate immunity could bring about restoration of immune responses in HIV disease.
authors.affiliation: Department of Infectious Diseases, Tourcoing Hospital Center, Tourcoing, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: De La Tribonniere
authors.forename: Yves
authors.initials: Y
authors.lastname: Mouton
authors.forename: Vincent
authors.initials: V
authors.lastname: Vidal
authors.forename: Edith
authors.initials: E
authors.lastname: Darcissac
authors.forename: Daouda
authors.initials: D
authors.lastname: Sissoko
authors.forename: Clothilde
authors.initials: C
authors.lastname: Fontier
authors.forename: Youcef
authors.initials: Y
authors.lastname: Douadi
authors.forename: Jo lle
authors.initials: Jl
authors.lastname: Dewulf
authors.forename: Corinne
authors.initials: C
authors.lastname: Amiel
authors.forename: George M
authors.initials: GM
authors.lastname: Bahr
mesh_terms: D000119:Acetylmuramyl-Alanyl-Isoglutamine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000633:toxicity*; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology; D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000633:toxicity*; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015703:Antigens, CD / Q000097:blood / Q000187:drug effects; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D006801:Humans; D007279:Injections, Subcutaneous; D008213:Lymphocyte Activation / Q000187:drug effects
chemical_list: D000276:Adjuvants, Immunologic; D019380:Anti-HIV Agents; D015703:Antigens, CD; D000119:Acetylmuramyl-Alanyl-Isoglutamine; C033575:murabutide