NCT00668356

Brief 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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
26

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 9, 2009

Status Verified

January 1, 2009

Enrollment Period

1 year

First QC Date

April 25, 2008

Last Update Submit

February 6, 2009

Conditions

HIV Infections

Keywords

HIV disease in childrenHIVchildrendidanosinebioequivalencepharmacokineticstreatment experienced

Outcome Measures

Primary Outcomes (1)

  • PK parameters

    28 days

Secondary Outcomes (2)

  • Biological analysis

    28 days

  • Quality of life

    28 days

Study Arms (2)

1

EXPERIMENTAL
Drug: didanosine

2

ACTIVE COMPARATOR
Drug: didanosine

Interventions

didanosineDRUG

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

2

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children treated by the didanosine capsules more than 3 months
  • viral load \< 50 copies/ml
  • written informed consent
  • Normal renal function

You may not qualify if:

  • Lack of observance
  • Any treatments which can interact with ddI
  • No written informed consent
  • Weight \> 60 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Necker

Paris, 75015, France

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

InosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Stephane Blanche, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2008

First Posted

April 29, 2008

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

February 9, 2009

Record last verified: 2009-01

Locations

FR(1)