title: Effect of food on the antiviral activity of didanosine enteric-coated capsules: a pilot comparative study.
abstract: OBJECTIVE
  To determine the effect of food on the antiviral activity of enteric-coated (EC) capsules of didanosine (ddI).
  
  
  METHODS
  We conducted a pilot, randomized, open-label study of 28-day ddI-EC capsules monotherapy-administered in a fasted state (group 1, n=11) or with food (group 2, n=10) to treatment-naïve chronically HIV-1-infected individuals. To assess the antiviral efficacy, HIV-1 RNA was determined at baseline, day 3, day 7 and weekly thereafter. The area under the HIV-1 RNA curve minus baseline weighted by time (AUCMB/day) was calculated.
  
  
  RESULTS
  Mean baseline HIV-1 RNA was 4.2 log(10) copies/mL in group 1 and 3.8 log(10) copies/mL in group 2. After 28 days, the mean HIV-1 RNA reduction was 0.99 log(10) copies/mL [95% confidence interval (CI) 0.45-1.53] for group 1 and 0.89 log(10) copies/mL (95% CI 0.38-1.40) for group 2. AUCMB/day values were 0.775 log(10) copies/mL (95% CI 0.33-1.22) and 0.774 log(10) copies/mL (95% CI 0.48-1.07), respectively, showing no difference in the rate of decrease of HIV-1 RNA (P=0.995). Mean ddI plasma levels at day 28 were 0.0234 mg/L for group 1 and 0.0227 mg/L for group 2 (P=0.96).
  
  
  CONCLUSIONS
  In this pilot study, the administration of food did not have any significant effect on the antiviral activity of ddI-EC capsules.
authors.affiliation: Department of Infectious Diseases, Hospital Ramón y Cajal, Madrid, Spain. bhernandez.hrc@salud.madrid.org
authors.forename: B
authors.initials: B
authors.lastname: Hernández-Novoa
authors.forename: A
authors.initials: A
authors.lastname: Antela
authors.forename: C
authors.initials: C
authors.lastname: Gutiérrez
authors.forename: J A
authors.initials: JA
authors.lastname: Pérez-Molina
authors.forename: M J
authors.initials: MJ
authors.lastname: Pérez-Elías
authors.forename: F
authors.initials: F
authors.lastname: Dronda
authors.forename: A
authors.initials: A
authors.lastname: Moreno
authors.forename: J L
authors.initials: JL
authors.lastname: Casado
authors.forename: C
authors.initials: C
authors.lastname: Page
authors.forename: M
authors.initials: M
authors.lastname: Pumares
authors.forename: J C
authors.initials: JC
authors.lastname: Galán
authors.forename: S
authors.initials: S
authors.lastname: Moreno
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018791:CD4 Lymphocyte Count; D002214:Capsules; D016049:Didanosine / Q000008:administration & dosage* / Q000097:blood; D004334:Drug Administration Schedule; D005215:Fasting; D005260:Female; D005502:Food / Q000009:adverse effects*; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood* / Q000187:drug effects; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000097:blood
chemical_list: D002214:Capsules; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D016049:Didanosine