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Bioequivalence Study of Didanosine in Children Treated for HIV (ddI)

This study has been suspended.
(questions of the benefit efficacy/risks of ddI during the meal not resolved)
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00668356
First received: April 25, 2008
Last updated: February 6, 2009
Last verified: January 2009
History of Changes

April 25, 2008
February 6, 2009
September 2009
September 2010   (final data collection date for primary outcome measure)
PK parameters [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00668356 on ClinicalTrials.gov Archive Site
  • Biological analysis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
Bioequivalence Study of Didanosine in Children Treated for HIV
PKPOP Study of Didanosine in HIV Treated Children, at Fasting Period and During the Meal

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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: didanosine
    28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting
    Other Name: didanosine
  • Drug: didanosine
    28 days 240 mg/m2/day during fasting 28 days 400 mg/m2/day during the meal
    Other Name: Didanosine
  • Experimental: 1
    Intervention: Drug: didanosine
  • Active Comparator: 2
    Intervention: Drug: didanosine
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
26
December 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00668356
P080101
No
Yannick VACHER, Department of Clinical Research of the Developpement
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Stephane Blanche, MD, PhD AP-HP
Assistance Publique - Hôpitaux de Paris
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP