title: Two-year safety and tolerability study of enfuvertide use in salvage therapy of Thai HIV-1 experienced cases.
abstract: OBJECTIVE
  To assess safety and tolerability of enfuvirtide, an antiretroviral, in Thai patients with advanced HIV-1 disease who have received antiretroviral treatment and failed on regimens that contain at least one of each antiretroviral (ARV) classes (PIs, NRTIs, and NNRTIs), or who have intolerance to previous antiretroviral regimens.
  
  
  METHODS
  An open-label non-comparative study of enfuvirtide used in salvage regimens along with the backbone antiretroviral therapy of choice in Thai HIV-1 experienced cases that have been treated with at least one of each available ARV classes.
  
  
  RESULTS
  Twenty-three patients were recruited from five participating centers. Seventeen patients (74%) completed 96 weeks of the treatment. Six patients prematurely withdrew from the present study in which three expired from HIV related complications, two withdrew consents, and one from adverse event. The most common adverse event is injection site reactions, which occurred in 22 patients. The manifestations and intensity varied from rash, erythema, edema, pain, induration, and bleeding at the injection sites, to inflammatory nodules. Most of the patients tolerated the treatment well. Enfuvirtide administered along with other antiretroviral combination provided a good control of the disease.
  
  
  CONCLUSIONS
  Enfuvirtide was well tolerated by Thai patients who participated in the present study. The adverse events did not compromise the patient compliance.
authors.affiliation: Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand. drwisit_p@yahoo.com
authors.forename: Wisit
authors.initials: W
authors.lastname: Prasithsirikul
authors.forename: Mattana
authors.initials: M
authors.lastname: Hanvanich
authors.forename: Surapol
authors.initials: S
authors.lastname: Suwanagool
authors.forename: Winai
authors.initials: W
authors.lastname: Ratanasuwan
authors.forename: Thanomsak
authors.initials: T
authors.lastname: Anekthananon
authors.forename: Wichai
authors.initials: W
authors.lastname: Techasathit
authors.forename: Khuanchai
authors.initials: K
authors.lastname: Supparatpinyo
authors.forename: Asda
authors.initials: A
authors.lastname: Viphagool
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D044466:Asian People; D018791:CD4 Lymphocyte Count; D024882:Drug Resistance, Viral / Q000187:drug effects / Q000276:immunology; D004359:Drug Therapy, Combination; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D016879:Salvage Therapy / Q000379:methods*; D013785:Thailand; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D000077560:Enfuvirtide