A Phase 2 interventional study of didanosine and didanosine in HIV Infections, sponsored by Assistance Publique - Hôpitaux de Paris. Suspended at 1 site in France. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2009-02-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
The purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in HIV infected children treated by a ARV combination including ddI
The didanosine is one of the reverse transcriptase inhibitors. This drug is efficient against the viral replication of the HIV. Licensing for the children was obtained in June, 1992. The main problem of the didanosine is its poor bioavailability: although gastro-resistant capsules were developed, its bioavailability remains dependent on alimentation. Taking a meal 1-2 hours before the administration of ddI leads to a reduction of 50% of its bioavailability as well for the child as for the adult. It is therefore recommended to take ddI during fasting period. This regimen in some cases can decrease therapeutic observance. A pharmacokinetic study of ddI will be conducted during the meal with 240 mg/m2/day during fasting period compare to 400 mg/m2/day during the meal. 26 patients, aged more than 6 years old, will be included and randomised in 2 groups. The first group will take the standard dose of ddI during 28 days during fasting period (phase A), then the high dose during the meal during 28 days (phase B). The second group will take first the phase B and secondly the phase A. Patients will be sequentially evaluated both after the first and the second period of treatment for pharmacokinetics and biological analysis.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's planned enrollment of 26 is below the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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Exclusion Criteria:
Drug: didanosine
Drug: didanosine
28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting
28 days 240 mg/m2/day during fasting 28 days 400 mg/m2/day during the meal
PK parameters
Time frame: 28 days
Biological analysis
Time frame: 28 days
Quality of life
Time frame: 28 days
The record gives a start of Sep 2009, a primary completion of Sep 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.
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This study is suspended, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Didanosine
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