Status:
SUSPENDED
Bioequivalence Study of Didanosine in Children Treated for HIV
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
HIV Infections
Eligibility:
All Genders
6-15 years
Phase:
PHASE2
Brief 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, i...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Children treated by the didanosine capsules more than 3 months
- viral load \< 50 copies/ml
- written informed consent
- Normal renal function
Exclusion
- Lack of observance
- Any treatments which can interact with ddI
- No written informed consent
- Weight \> 60 kg
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00668356
Start Date
September 1 2009
End Date
December 1 2010
Last Update
February 9 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Necker
Paris, France, 75015