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Clinical Trials

MainTitle

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

This study has been suspended
Sponsor
Assistance Publique - Hôpitaux de Paris


Information provided by (Responsible Party)
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
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : didanosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PKPOP Study of Didanosine in HIV Treated Children, at Fasting Period and During the Meal

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures

  • PK parameters [ Time Frame: 28 days ]
Secondary Outcome Measures:
  • Biological analysis [ Time Frame: 28 days ]
  • Quality of life [ Time Frame: 28 days ]

Estimated Enrollment: 26
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 1

Drug: didanosine

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

Active Comparator: 2

Drug: didanosine

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

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.

Eligibility

Eligibility

Ages Eligible for Study: 6 Years to 15 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668356

Locations

France
Hopital Necker
Paris, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Stephane Blanche, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information

More Information


Responsible Party: Yannick VACHER, Department of Clinical Research of the Developpement  
ClinicalTrials.gov Identifier: NCT00668356   History of Changes  
Other Study ID Numbers: P080101  
Study First Received: April 25, 2008  
Last Updated: February 6, 2009  

Keywords provided by Assistance Publique - Hôpitaux de Paris:

HIV disease in children
HIV
children
didanosine
bioequivalence
pharmacokinetics
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Didanosine

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.