EUCTR2004-002050-66-IE进行中（未招募）1 期
Treatment Interruption in Children with Chronic HIV-Infection: the TICCH Trial - The TICCH trial
PENTA Foundation0 个研究点目标入组 100 人开始时间: 2004年9月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Aged 2-15 years inclusive.
- •2. Parents/guardians, and children where appropriate, willing and able to give informed consent .
- •3. Children currently on the same regimen of 3 or more antiretroviral drugs for at least 24 weeks.
- •4. Children and parents prepared to restart the same regimen after treatment interruption if CD4% falls to < 20% (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 RNA viral load <50 copies/ml (at least one month apart)
- •6. Most recent two CD4% > 30% with TLC >1000 (at least one month apart); most recent two CD4% should be stable (different by no more than 4%).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Cannot and unwilling to attend regularly
- •2. Unwilling to restart ART if CD4% 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
相似试验
已完成
不适用
Treatment Interruption in Children with Chronic Human immunodeficiency virus infection: the TICCH TrialPaediatric Human Immunodeficiency Virus (HIV)Infections and InfestationsISRCTN36694210The Paediatric European Network for the Treatment of AIDS (PENTA) Foundation (Italy)100
已完成
2 期
Follow-up Safety Trial in children with chronic heart failure therapy receiving Orodispersible Minitablets of Enalapril (WP10 Trial).hartaandoeningen, myocardaandoeningen10010394Dilated CardiomyopathyCongenital Heart DiseaseNL-OMON46324Ethicare GmbH11
进行中（未招募）
不适用
INTERRUPCIÓN DEL TRATAMIENTO EN NIÑOS CON INFECCIÓN CRÓNICA POR VIHVIH-SIDA EN NIÑOSEUCTR2004-002050-66-ESPENTA100
进行中（未招募）
1 期
FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIHeart Failure due to Dilated Cardiomyopathy and Congenital Heart DiseaseMedDRA version: 18.1Level: LLTClassification code 10010495Term: Congenital heart disease NOSSystem Organ Class: 100000004850MedDRA version: 18.1Level: LLTClassification code 10056419Term: Dilated cardiomyopathySystem Organ Class: 100000004849EUCTR2015-002397-21-HUEthicare GmbH100
进行中（未招募）
不适用
FOLLOW-UP SAFETY TRIAL IN CHILDREN WITH CHRONIC HEART FAILURE THERAPY RECEIVING ORODISPERSIBLE MINITABLETS OF ENALAPRIEUCTR2015-002397-21-NLEthicare GmbH100