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Bioequivalence Study of Didanosine in Children Treated for HIV

NCT00668356 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2009-02-09

No results posted yet for this study

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

Conditions

  • HIV Infections

Interventions

DRUG

didanosine

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

DRUG

didanosine

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Stephane Blanche, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668356 on ClinicalTrials.gov