ISRCTN36694210已完成未知
Treatment Interruption in Children with Chronic Human immunodeficiency virus infection: the TICCH Trial
The Paediatric European Network for the Treatment of AIDS (PENTA) Foundation (Italy)0 个研究点目标入组 100 人开始时间: 2004年2月25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
- 100
研究概览
简要总结
2008 Results article in http://www.ncbi.nlm.nih.gov/pubmed/18419497 results 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20010073 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23135172 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34475868/ Follow up study (added 06/09/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria amended as of 24/09/2007:
- •1. Aged 2 to 15 years inclusive
- •2. Parents/guardians, and children where appropriate, willing and able to give informed consent
- •3. Children currently on the same regimen of three or more antiretroviral (ART) drugs for at least 24 weeks
- •4. Children and parents prepared to restart the same ART regimen after treatment interruption if CD4% falls to <20% (children aged 2-6 years) or CD4% falls to <20% or CD4 count falls to <350 cells/mm3 (children aged >7 years) (confirmed on a second sample) or after 48 weeks on a PTI
- •5. Most recent two plasma HIV-1 Ribonucleic Acid (RNA) viral load less than 50 copies/ml (at least one month apart)
- •6. Most recent two CD4% >30% (children aged 2-6 years) or most recent two CD4% >25% and CD4 count >500 cells/mm3 (children aged >7 years); most recent two CD4% should be stable (different by no more than 4%)
- •7. Most recent two Total Lymphocyte Count (TLC) more than 1000 (at least one month apart)
- •8. Willing to attend 4 weekly monitoring visits if CD4 declines to <400 cells/mm3 or CD4% <22%
- •Inclusion criteria provided at time of registration:
- •1. Aged 2 to 15 years inclusive
- •2. Parents/guardians, and children where appropriate, willing and able to give informed consent
- •3. Children currently on the same regimen of three or more antiretroviral (ART) drugs for at least 24 weeks
- •4. Children and parents prepared to restart the same ART regimen after treatment interruption if CD4% falls below 20% (aged two to six years) or CD4% falls to less than 20% and CD4 count falls to less than 350 cells/mm^3 (confirmed on a second sample). Children and parents prepared to continue on current therapy until clinical or virological failure if randomised to the continuous therapy arm
- •5. Most recent two plasma HIV-1 Ribonucleic Acid (RNA) viral load less than 50 copies/ml (at least one month apart)
- •6. Most recent two CD4% equal 30% (children aged two to six years) or most recent two CD4% equals 25% and CD4 count is more than 350 cells/mm^3. Most recent two CD4% should be stable (different by no more than 4%)
- •7. Most recent two Total Lymphocyte Count (TLC) more than 1000 (at least one month apart)
排除标准
- •Exclusion criteria amended as of 24/09/2007:
- •1. Cannot or unwilling to attend regularly
- •2. Unwilling to restart ART if CD4 percent or count indicates this is necessary
- •3. Intercurrent illness (randomisation can take place after the illness)
- •4. Pregnancy or risk of pregnancy in girls of child-bearing potential
- •5. Previous symptomatic thrombocytopaenia with platelets <50 x 10 (to the power of 9)/l
- •6. Positive for hepatitis B surface antigen and receiving either lamivudine or tenofavir
- •Exclusion criteria provided at time of registration:
- •1. Cannot or unwilling to attend regularly
- •2. Unwilling to restart ART if CD4 percent or count indicates this is necessary
- •3. Intercurrent illness (randomisation can take place after the illness)
- •4. Pregnancy or risk of pregnancy in girls of child-bearing potential
研究者
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