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document
Effect of food on the antiviral activity of didanosine enteric-coated capsules : a pilot comparative study . OBJECTIVES 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 .
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Intervention_Pharmacological
food
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Intervention_Pharmacological
didanosine enteric-coated capsules
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Intervention_Pharmacological
food
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Intervention_Pharmacological
enteric-coated ( EC ) capsules of didanosine ( ddI )
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Intervention_Pharmacological
ddI-EC capsules monotherapy-administered
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Intervention_Psychological
fasted state
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Intervention_Pharmacological
with food
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Outcome_Other
antiviral activity