Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273975
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2006-01-09
Brief Title:
Trial to Evaluate Steady State Pharmacokinetic Parameters Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic Efficacy and Safety Parameters of Nevirapine 150mgm2 and Nevirapine 4 or 7 mgkg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric Patients
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mgm2 and nevirapine 4 or 7 mgkg after 4 weeks and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve paediatric patients
Detailed Description:
A randomised open label multi-centre trial to evaluate the pharmacokinetic efficacy and safety parameters of nevirapine 150mgm2 and nevirapine 4 or 7mgkg when administered in combination with ZDV and 3TC for 48 weeks in antiretroviral naive pediatric patients
Primary objective To evaluate steady state pharmacokinetic parameters of nevirapine 150mgm2 in antiretroviral drug naive pediatric patients
Secondary objective To assess efficacy and safety of nevirapine 150 mgm2 and nevirapine 47mgkg after 24 and 48 weeks of treatment
Study Hypothesis
Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations The goal in this study was to determine if a Nevirapine suspension dose of 150 mgm2 BID following a two week lead-in of 150 mgm2 QD produces plasma nevirapine steady state concentrations of 4 - 6 gmL in all age groups as was observed in adult safety and efficacy trials
Comparisons
ACTG 245
Primary objective To evaluate steady state pharmacokinetic parameters of nevirapine 150mgm2 in antiretroviral drug naive pediatric patients
Secondary objective To assess efficacy and safety of nevirapine 150 mgm2 and nevirapine 47mgkg after 24 and 48 weeks of treatment
Study Hypothesis
Evaluation of recent pharmacokinetic data has suggested that a dose based on body surface area rather than body weight might be a better therapeutic regimen to achieve steady state plasma concentrations The goal in this study was to determine if a Nevirapine suspension dose of 150 mgm2 BID following a two week lead-in of 150 mgm2 QD produces plasma nevirapine steady state concentrations of 4 - 6 gmL in all age groups as was observed in adult safety and efficacy trials
Comparisons
ACTG 245
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None