PACTR201006000222401已完成未知
A randomised trial to compare toxicity and pharmacokinetics of three fixed-dose combination based antiretroviral regimens for treatment of human immunodeficiency virus (HIV) infected children in Africa
Medical Research Council - Clinical Trials Unit0 个研究点目标入组 420 人开始时间: 2010年6月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 420
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
- 年龄范围
- 1 Month(s) 至 13 Year(s)（—）
- 性别
- All
入选标准
- •1. Age one month to 13 years, either sex
- •1.1 ART naive children in Uganda being randomised to commence therapy on a d4T based regimen must be 0 - 4 years old in accordance with local guidelines
- •1.2 ART experienced chidlren being randomised to continue therapy on d4T based regimen must be 5yr or older with no clincial symptoms of lipodystrophy. If symptoms of severe lipodystropy then will switch to another regimen.
- •2. Weighing greater than 3kg and less than 25kg (heavier children should receive adult tablets and not be enrolled in CHAPAS-3)
- •3. Participants must have a confirmed diagnosis of HIV-1 infection
- •4. Parents or guardians, and children where appropriate accordign to age and knowledge of HIV status, must be willing adn bale to give informed consent for randomisation to first-line ART strategy and participation in the PK substudy if eligible
- •5.1 ART naive (except for exposure to perinatal ART for the prevention of mother to child HIV transmission), meeting World Health Organization (WHO)or national (WHO modified) criteria for initiating therapy and ready to start initial 2NRTI+NNRTI based regimen according to local guidelines (i.e., according to WHO stage/CD4 and guielines concerning first-line ART in children who have been exposed to NVP perinatally) or
- •5.2 Currently taking d4T based regimen for at least 2 years with screenign HIV RNA viral load less than 50 copies/ml, no history of recieving other ARV drugs and CD4 count and/or CD4 percent stable over the previous 6 months
- •6. Able and willing to take each of the possible regimens
排除标准
- •1. Cannot or unlikely to attend regularly (e.g. usual residence too far from study centre)
- •2. Likelihood of poor attendance
- •3. Presence of acute infection
- •4. In receipt of medication contraindicated by ART or on chemotherapy for malignancy. Children under three years of age receiving anti-tuberculosis therapy should not be enrolled ( as they will have to receive nevirapine)
- •5. Laboratory abnormalities which are a contra-indication for teh child to start ART/change to any of the possible 3 regimens
- •6. Being pregnant of breast-feeding an infant
- •7. Perinatal exposure to NVP (either through pMTCT or breastfeeding) for children aged 3 - 6 months only
研究者
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