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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00273975
First received: January 9, 2006
Last updated: October 30, 2013
Last verified: October 2013

January 9, 2006
October 30, 2013
January 2002
December 2004   (final data collection date for primary outcome measure)
  • Area under the concentration-time curve over one dosing interval (AUCτ) [ Time Frame: 1, 3 and 6 hours on Day 28 ] [ Designated as safety issue: No ]
  • Maximum observed concentration (Cmax) [ Time Frame: 1, 3 and 6 hours on Day 28 ] [ Designated as safety issue: No ]
  • Minimum observed concentration (Cmin) [ Time Frame: 1, 3 and 6 hours on Day 28 ] [ Designated as safety issue: No ]
  • Oral clearance (Dose/AUC) at steady state [ Time Frame: 1, 3 and 6 hours on Day 28 ] [ Designated as safety issue: No ]
Primary endpoint; The dose of nevirapine (150mg/m2, not to exceed 200mg, BID) administered to paediatric patients provides drug plasma levels similar to the nevirapine exposure as observed in adults taking nevirapine 200mg BID
Complete list of historical versions of study NCT00273975 on ClinicalTrials.gov Archive Site
  • Change in HIV-1 RNA count [ Time Frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48 ] [ Designated as safety issue: No ]
  • Virologic Response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Time to Virologic Suppression [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Virologic Failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Time to Virologic Failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Treatment Failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change in CD4+ cell count [ Time Frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48 ] [ Designated as safety issue: No ]
  • Change in CD4+ percent [ Time Frame: week 2, 4, 8, 12, 18, 24, 30, 36, 42,48 ] [ Designated as safety issue: No ]
  • Occurrence of Adverse Events [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Occurrence of Rash [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
An assessment of the efficacy and safety of 150mg/m2 BID nevirapine and 4/7 mg/kg BID nevirapine
Not Provided
Not Provided
 
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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Nevirapine
  • Drug: Lamivudine
  • Drug: Zidovudine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
December 2004
December 2004   (final data collection date for primary outcome measure)

Inclusion:

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

Exclusion:

  1. Any significant disease, other than HIV
  2. Any acute illness within 2 weeks prior to Day 0
  3. Patients requiring the continued use of inhibitors or inducers of P450 metabolic enzymes
  4. Patients requiring systematic treatment with CYP3A4 substrates
  5. Patients with malabsorption, severe chronic diarrhea
  6. Receipt of any cytotoxic therapy for malignancy
  7. Current grade 3 or 4 clinical or laboratory toxicity
  8. Pregnancy or breast-feeding
  9. 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
Both
3 Months to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00273975
1100.1368
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator B.I. South Africa (Pty.) Ltd.
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP