Bioequivalence Study of Didanosine in Children Treated for HIV

NCT ID: NCT00668356

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

didanosine

Intervention Type: DRUG

28 days 240 mg/m2/day during fasting 28 days 400 mg/m2/day during the meal

2

Group Type: ACTIVE_COMPARATOR

didanosine

Intervention Type: DRUG

28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting

Interventions

didanosine

28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting

Intervention Type: DRUG

didanosine

28 days 240 mg/m2/day during fasting 28 days 400 mg/m2/day during the meal

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Department of Clinical Research of the Developpement

Principal Investigators

Stephane Blanche, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hopital Necker

Paris, , France

Countries

France

Other Identifiers

P080101

Identifier Type: -

Identifier Source: org_study_id