Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00273975
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg 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 150mg/m2 and nevirapine 4 or 7mg/kg 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 150mg/m2 in antiretroviral drug naive pediatric patients.

Secondary objective: To assess efficacy and safety of nevirapine 150 mg/m2 and nevirapine 4/7mg/kg 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 mg/m2 BID, following a two week lead-in of 150 mg/m2 QD, produces plasma nevirapine steady state concentrations of 4 - 6 ?g/mL in all age groups as was observed in adult safety and efficacy trials.

Comparison(s):

ACTG 245

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve over one dosing interval (AUCτ)	1, 3 and 6 hours on Day 28
Maximum observed concentration (Cmax)	1, 3 and 6 hours on Day 28
Minimum observed concentration (Cmin)	1, 3 and 6 hours on Day 28
Oral clearance (Dose/AUC) at steady state	1, 3 and 6 hours on Day 28

Secondary Outcome Measures

Name	Time	Method
Virologic Response	48 weeks
Virologic Failure	48 weeks
Time to Virologic Failure	48 weeks
Treatment Failure	48 weeks
Time to Treatment Failure	48 weeks
Occurrence of Rash	48 weeks
Time to Virologic Suppression	48 weeks
Occurrence of Adverse Events	48 weeks
Change in HIV-1 RNA count	week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Change in CD4+ percent	week 2, 4, 8, 12, 18, 24, 30, 36, 42,48
Change in CD4+ cell count	week 2, 4, 8, 12, 18, 24, 30, 36, 42,48

Trial Locations

Locations (2)

Boehringer Ingelheim Investigational Site; 🇿🇦 Tygerberg, South Africa

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa