Bioequivalence Study of Didanosine in Children Treated for HIV

Phase 2

Suspended

• Conditions: HIV Infections
• Interventions: Drug: didanosine

• Registration Number: NCT00668356
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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, in HIV infected children treated by a ARV combination including ddI

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 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.

Study Timeline

• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Status Verified: 2009-01
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09
• Study Start: 2009-09
• Primary Completion: 2010-09
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	didanosine	-
1	didanosine	-

Primary Outcome Measures

Name	Time	Method
PK parameters	28 days

Secondary Outcome Measures

Name	Time	Method
Biological analysis	28 days
Quality of life	28 days

Trial Locations

Locations (1)

Hopital Necker; 🇫🇷 Paris, France