Bioequivalence Study of Didanosine in Children Treated for HIV

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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PKPOP Study of Didanosine in HIV Treated Children, at Fasting Period and During the Meal

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: didanosine
* Drug: didanosine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children treated by the didanosine capsules more than 3 months viral load < 50 copies/ml written informed consent Normal renal function Exclusion Criteria: Lack of observance Any treatments which can interact with ddI No written informed consent Weight > 60 kg

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: didanosine<br>* 28 days 240 mg/m2/day during fasting 28 days 400 mg/m2/day during the meal<br>|
| Active Comparator: 2<br> | Drug: didanosine<br>* 28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological analysis |  | 28 days | 
| Quality of life |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV disease in children, HIV, children, didanosine, bioequivalence, pharmacokinetics, treatment experienced