Status:
COMPLETED
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
HIV Infections
Eligibility:
All Genders
3-16 years
Phase:
PHASE2
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 anti...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00273975
Start Date
January 1 2002
End Date
December 1 2004
Last Update
October 31 2013
Active Locations (4)
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1
Groote Schuur Hospital
Cape Town, South Africa, 7900
2
Boehringer Ingelheim Investigational Site
Pretoria, South Africa
3
Boehringer Ingelheim Investigational Site
Soweto, South Africa, 2013
4
Boehringer Ingelheim Investigational Site
Tygerberg, South Africa, 7505