Bioequivalence Study of Didanosine in Children Treated for HIV

HIV Infections Clinical Trial

— ddI  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00668356
• Other study ID #: P080101
• Status: Suspended
• Phase: Phase 2
• First received: April 25, 2008
• Last updated: February 6, 2009
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 26
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• didanosine
28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting
• didanosine
28 days 240 mg/m2/day during fasting 28 days 400 mg/m2/day during the meal

Locations

Country	Name	City	State
France	Hopital Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters		28 days	Yes
Secondary	Biological analysis		28 days	Yes
Secondary	Quality of life		28 days	Yes