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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Lamivudine; Nevirapine; Zidovudine

Criteria

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