NL-OMON44252已完成4 期
Once daily DArunavir/ritonavir in HIV-infected children 6-12 years old: a PHarmacokiNEtic validation of model-based dosing recommendations (DAPHNE) - DAPHNE
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •1. Parents/carers are able and willing to sign the informed consent form prior to screening evaluations
- •2. Subject is HIV infected
- •3. Subject is at least 6 and not older than 12 years at day of screening
- •4. Subject has a body weight of at least 15kg
- •5. Subject is able to swallow tablets
- •6. Subject has an undetectable viral load (<50 copies/mL) for the last 6 months prior to screening (at least 2 measurements)
- •7. ART regimen consists of darunavir/ritonavir and 2 NRTIs
排除标准
- •1. Inability to understand the nature and extent of the trial and the procedures required
- •2. Documented history of sensitivity/idiosyncrasy to darunavir or ritonavir medicinal products or its excipients
- •3. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion
- •4. Abnormal renal or liver function (grade 3 or above)
- •5. Participation in a drug trial within 60 days prior to the first dose
- •6. Hemoglobin < 10 g/dL (6.0 mmol/L)
- •7. Children who have previously failed virologically on a PI containing regimen
- •8. Acute illness
- •9. Receiving concomitant therapy except for prophylaxis for opportunistic infections.
研究者
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