ISRCTN31084535已完成不适用
Children with human immunodeficiency virus (HIV) in Africa - Pharmacokinetics and Adherence of Simple Antiretroviral Regimens
Medical Research Council (UK)0 个研究点目标入组 200 人开始时间: 2006年2月23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
- 200
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. Aged 3 months to 14 years inclusive
- •2. Less than 30 kg in weight (heavier children should receive Triomune 30 and not be enrolled in the CHAPAS 1 trial)
- •3. Carers and children where appropriate, willing and able to give informed consent
- •4. HIV-infected, as determined by:
- •a. Two separate HIV-antibody enzyme-linked immunosorbent assay (ELISA) or rapid tests on the same sample in children >18 months
- •b. Two positive proviral DNA tests taken on separate samples in children <18 months
- •5. Previously untreated with antiretrovirals, including any ART given to prevent mother to child transmission
- •6. Fulfilling one of the World Health Organisation (WHO) criteria for initiating treatment:
- •a. WHO paediatric stage 4 or severe stage 3 disease regardless of CD4 %
- •b. CD4 percent <15% if >18 months of age, or <20% if <18 months of age
- •c. WHO paediatric stage 2 disease with consideration of CD4 percentage (<15% for children >18 months; <20% for children <18 months)
- •(Note current WHO guidelines are under review and the above criteria may be changed, particularly by raising the CD4 percentage cut-off to 25% in children <18 months; inclusion criteria would be changed accordingly for children to start ART in CHAPAS 1 trial.)
排除标准
- •1. Cannot or unwilling to regularly attend the CHAPAS clinic
- •2. Severe laboratory abnormalities (contra-indicating NVP based regimen) i.e. serum creatinine >5 times upper limit of normal (ULN) or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >10 times ULN
- •3. Active opportunistic infection and/or serious bacterial infection at the time of study entry including tuberculosis (TB) (children may be enrolled after the acute phase)
- •4. Current treatment with any medication known to be contra-indicated with any of the drugs prescribed for the patient's ART-therapy in this trial, including rifampicin
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