HIV-1 infected children under antiretroviral therapy
Conditions
Interventions
Product Name: Nevirapine tablets, Extended Release, 400 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Nevirapine
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent of a parent or legal guardian prior to admission to the study in accordance with GCP and the local laws and regulations. Active assent must be given by the patient if the child and/or adolescent is capable of understanding the provided study information [based on the local laws and regulations of each country and site]. 2. HIV-1 infected males or females = 3 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any AIDS-related or AIDS defining illness that is unresolved or not stable on treatment at least 8 weeks prior to screening visit. 2. Diseases other than HIV infection or conditions that, in the investigator's opinion, would interfere with the study. 3. Patients who have been diagnosed with malignant disease and who are receiving systemic chemotherapy or are anticipated to receive any therapy during their participation in this trial. 4. Use of investigational medications or vaccines within 28 days prior to Visit 1 or during the trial. 5. Use of immunomodulatory drugs within 28 days before Visit 1 or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2). 6. Concomitant protease inhibitor (PI) treatment. 7. Unwillingness to abstain from ingesting substances during the study which may alter plasma drug concentrations by interaction with the cytochrome P450 system 8. Female patients of childbearing potential who: • have a positive serum pregnancy test at screening, • are breast feeding, • are planning on becoming pregnant, • are not willing to use double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception, or require ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, cervical caps and condoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the pharmacokinetic (PK) parameters at steady-state of once-daily (QD) nevirapine (NVP) extended release (XR) in children aged 3 to 17 years under fasting conditions.;Secondary Objective: Safety, tolerability and efficacy of nevirapine extended release.;Primary end point(s): The primary endpoints will be morning trough Cpre,N, AUCt,ss, Cmin,ss and Cmax,ss. • Cpre,N (trough drug concentration immediately prior to the next scheduled dose) • AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time dosing interval t) • Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over the time dosing interval t) • Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over the time dosing interval t);Timepoint(s) of evaluation of this end point: After completion of day study day 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cmax,ss /Cmin,ss, %PTF, tmax,ss, CL/F,ss, and Cavg will be reported as descriptive statistics. The following three efficacy endpoints will be analyzed descriptively: 1. Proportion of patients maintaining a viral load < 50 copies/mL at Day 22 and Week 24, 2. Proportion of patients maintaining a viral load < 400 copies/mL at Day 22 and Week 24, 3. Change in mean CD4 count (absolute and percentage) from baseline at Day 22 and Week 24.;Timepoint(s) of evaluation of this end point: After completion of day study day 22 and after completion of optional extension if applicable | — |
Countries
Botswana, Germany, South Africa, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed