Bioequivalence Study of Didanosine in Children Treated for HIV (ddI)
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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 |
- PK parameters [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- 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 |
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 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 May 16, 2013