drugset / Trial / NCT00273975
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2002-01
- Primary completion
- 2004-12
- Completion
- 2004-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nevirapine | Small molecule | 4 mg/kg | — |
| Subject | Nevirapine | Small molecule | 7 mg/kg | — |
| Subject | Nevirapine | Small molecule | 150 mg/m2 | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Zidovudine | Small molecule | — | — |