Effect of food on the antiviral activity of didanosine enteric-coated capsules: a pilot comparative study.
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.
Hernández-Novoa
B
B
Department of Infectious Diseases, Hospital Ramón y Cajal, Madrid, Spain. bhernandez.hrc@salud.madrid.org
Antela
A
A
Gutiérrez
C
C
Pérez-Molina
J A
JA
Pérez-Elías
M J
MJ
Dronda
F
F
Moreno
A
A
Casado
J L
JL
Page
C
C
Pumares
M
M
Galán
J C
JC
Moreno
S
S
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
D002214:Capsules; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D016049:Didanosine