EUCTR2010-024537-23-GB进行中（未招募）1 期
A Prospective Single Arm, Open-Label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder boosted with Ritonavir (RTV) with an Optimized NRTI Background Therapy, in HIV Infected, Antiretroviral, Naive and Experienced Pediatric Subjects from 3 Months to Less Than 11 Years Pediatric Atazanavir International Clinical Evaluation: the PRINCE II study Revised Protocol Number 04, incorporates amendment 07 and Administrative letter 01 - PRINCE II
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
入选标准
- •Confirmed HIV 1 infection diagnosed by protocol criteria
- •Screening HIV RNA = 1000 copies/mL
- •= 3 months to < 11 years of age at time of first treatment
- •antiretroviral naive or experienced
- •all subjects must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country.
- •antiretroviral-experienced subjects must also have documented phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and to at least 2 NRTIs that are approved in their country
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 95
- •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
- •Experienced subjects who received ATV or ATV/RTV at any time prior to study enrollment or who
- •have prior history of 2 or more PI failures
- •Antiretroviral-naïve or experienced HIV-1 infected patients with contraindication to study medications
- •Cardiac rhythm abnormalities
- •Need for Tenofovir
- •Weight < 5kg or =35kg
- •> Grade 2 AST/ALT
- •Coinfection with either HBV or HCV
- •Any active CDC Category C clinical condition
研究者
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