EUCTR2008-005855-61-DE进行中（未招募）不适用
An open-label, multiple dose, cross-over study to evaluate the steady-state pharmacokinetic parameters of nevirapine extended release tablets in HIV-1 infected children, with an optional extension phase.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •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
排除标准
- •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
研究者
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