Bioequivalence Study of Didanosine in Children Treated for HIV

• Status: Suspended
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Didanosine

Criteria

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