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

This study has suspended participant recruitment.
(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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PKPOP Study of Didanosine in HIV Treated Children, at Fasting Period and During the Meal

Resource links provided by NLM:


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

Primary Outcome Measures:
  • PK parameters [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biological analysis [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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
Other Name: Didanosine
Active Comparator: 2 Drug: didanosine
28 days 400 mg/m2/day during the meal 28 days 240 mg/m2/day during fasting
Other Name: didanosine

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

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
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
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 AP-HP
  More Information

No publications provided

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
Health Authority: France: Ministry of Health

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 20, 2014