EUCTR2008-005855-61-Outside-EU/EEA进行中（未招募）不适用
An open-label, multiple dose, cross-over study to evaluate thesteady-state pharmacokinetic parameters of nevirapine extended release tablets in HIV-1 infected children, with an optional extension phase.
Boehringer Ingelheim (Pty) Ltd0 个研究点目标入组 75 人开始时间: 2011年8月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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: 75
- •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
相似试验
进行中（未招募）
不适用
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.HIV-1 infected children under antiretroviral therapyEUCTR2008-005855-61-DEBoehringer Ingelheim Pharma GmbH & Co. KG75
尚未招募
不适用
Pharmacokinetic interaction of donepezil and herbal medicinesKCT0007588Yonsei University Health System, Severance Hospital36
招募中
1 期
Study to measure filgotinib in the blood of children and teenagers with arthritis taking filgotinib-GLPG0634-CL-131MedDRA version: 21.0Level: PTClassification code: 10059176Term: Juvenile idiopathic arthritis Class: 100000004859juvenile idiopathic arthritisCTIS2023-505844-21-00Galapagos55
进行中（未招募）
不适用
A Study of Intravenous Mircera for the Treatment of Anemia in Pediatric Patients on Hemodialysis.Anemia associated with chronic kidney disease in pediatric patients (CKD) on hemodialysisMedDRA version: 17.0Level: LLTClassification code 10058124Term: Nephrogenic anemiaSystem Organ Class: 100000004851EUCTR2007-007758-70-HUF. Hoffmann-La Roche Ltd68
进行中（未招募）
1 期
An open-label multi-center, multiple dose study to determine the optimum starting dose of intravenous MIRCERA® for maintenance treatment of anemia in pediatric patients with chronic kidney disease on hemodialysisAnemia associated with chronic kidney disease in pediatric patients (CKD) on hemodialysisMedDRA version: 9.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaEUCTR2007-007758-70-FRF. Hoffmann-La Roche Ltd41