ISRCTN55748789已完成不适用
Effectiveness of generic split adult tablets and paediatric fixed dose combination (FDC) of d4T/3TC/NVP in the treatment of HIV infected Malawian children: A part open-label randomised controlled trial and part cohort study
Ministry of Health (Malawi) - HIV department0 个研究点目标入组 410 人开始时间: 2010年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 410
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Confirmed HIV infection (either HIV antibody test or, if <18 months, by HIV DNA test)
- •2. Caregiver and child, if applicable, counselled about HIV infection
- •3. Age <15 years
- •4. Body weight =3kg and <25kg
- •5. Informed consent given by caregiver and child if applicable
- •6. Eligible to start Anti-Retroviral Therapy (ART) according to Malawi National ART guidelines (3rd edition 2008)
- •7. Likely to comply with the study protocol (e.g. a main caregiver, responsible for administrating medication has been identified, caregiver and child have undergone an ART education session using the national paediatric ART education flipchart to understand the implications of ART, patient lives within the Lilongwe district)
排除标准
- •1. Previous exposure to ART except Prevention of Mother-To-Child Transmission (PMTCT)
- •2. Patient requires hospital admission according to assessment of study clinician
- •3. Obvious liver disease on clinical examination (e.g. jaundice)
- •4. Obvious renal disease on clinical examination (e.g. lid oedema, hypertension)
研究者
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