Study to investigate the behaviour and properties of nevirapine extended release tablets in humans when given to children who are infected with HIV-1, with an optional extension phase.
- Conditions
- HIV-1 infected children under antiretroviral therapyTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2008-005855-61-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
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 < 18 years old.
Final,
BI Trial No.: Trial Protocol Page
Boehringer Ingelheim 4 Dec 2008
1100.1518 28
3. BSA = 0.58 m2 for patients using BSA to calculate nevirapine IR dose; or BW
= 12.5 kg for patients using BW to calculate nevirapine IR dose, at screening visit.
4. Treated with a nevirapine IR based regimen for at least 18 weeks prior to screening
visit (Visit 1); no modifications in the ARV background therapy within the last
2 weeks prior to screening, and the expectancy to stay under the same antiviral
regimen for at least 30 weeks.
5. An HIV viral load of <50 copies/mL while receiving nevirapine IR at the last measure
of VL documented in the medical record obtained within a period of 5 months prior to
screening visit.
6. An HIV viral load of <50 copies/mL at screening visit.
7. A stable or not decreasing CD4+ cell count according to the investigator’s opinion.
8. Acceptable screening laboratory values that indicate adequate baseline organ function
according to the investigator’s opinion.
9. ALT and AST = 2.5 X ULN (DAIDS Grade 1).
10. Serum creatinine levels = 1.3 X ULN (DAIDS Grade 1).
11. Patients able to swallow tablets.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the pharmacokinetic (PK) parameters at steady-state of once-daily (QD)<br>nevirapine (NVP) extended release (XR) in children aged 3 to 17 years under fasting<br>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.<br>• Cpre,N (trough drug concentration immediately prior to the next scheduled dose)<br>• AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady<br>state over the time dosing interval t)<br>• Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over<br>the time dosing interval t)<br>• Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over<br>the time dosing interval t);Timepoint(s) of evaluation of this end point: After completion of day study day 22
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Cmax,ss /Cmin,ss, %PTF, tmax,ss, CL/F,ss, and Cavg will be reported as descriptive statistics.<br>The following three efficacy endpoints will be analyzed descriptively:<br>1. Proportion of patients maintaining a viral load < 50 copies/mL at Day 22 and Week 24,<br>2. Proportion of patients maintaining a viral load < 400 copies/mL at Day 22 and Week 24,<br>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