Trial | NCT00273975  Report issue

Title

Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
A Randomised Open Label Multi-centre Trial to Evaluate the Pharmacokinetic, Efficacy and Safety Parameters of Nevirapine 150mg/m2 and Nevirapine 4 or 7 mg/kg When Administered in Combination With AZT and 3TC for 48 Weeks in Antiretroviral naïve Paediatric Patients.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    123
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.
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 Started
Jan 31
2002
Primary Completion
Dec 31
2004
Study Completion
Dec 31
2004
Last Update
Oct 31
2013
Estimate

Drug Nevirapine

Drug Lamivudine

Drug Zidovudine

Criteria 

Inclusion:

Male or female patients between 3 months and 16 years of age at day 28 of the study.
Evidence of HIV-1 infection
Patients who are antiretroviral drug naive
Plasma viral load detectable
CD4 >=50 cells/cc3
Written informed permission
Active assent given by the patient if the child is capable of understanding the given information
Reasonable probability for completion of the trial

Exclusion:

Any significant disease, other than HIV
Any acute illness within 2 weeks prior to Day 0
Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
Patients requiring systematic treatment with CYP3A4 substrates
Patients with malabsorption, severe chronic diarrhea
Receipt of any cytotoxic therapy for malignancy
Current grade 3 or 4 clinical or laboratory toxicity
Pregnancy or breast-feeding
Females of childbearing potential not using adequate contraception. allergy or known drug hypersensitivity to any of the study drugs intravenous drug abuse, alcohol or substance abuse
No Results Posted