RBR-3vmkt2进行中（未招募）2 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) Liquid with an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years. (Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study)
Bristol-Myers Squibb0 个研究点开始时间: 2011年6月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 3M 至 5Y（—）
入选标准
- •HIV 1 infection diagnosed by protocol criteria. >= 3 months to < 5 years and 6 months of age at time of first treatment, and weight > 5 to < 25kg with any screening baseline plasma viral load. Antiretroviral naive and experienced. Screening HIV RNA >= 1000 copies/mL. Must have genotypic sensitivity at screening to ATV and at least 2 NRTIs. NRTIs must be approved for pediatric use at the local country. Subjects must have documented genotypic and phenotypic sensitivity at screening to ATV (Fold Change in susceptibility < 2.2) and to at least 2 NRTIs that are approved in their country.
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. Family history of QTc interval syndrome, Brugada syndrome or right ventricular dysplasia or with a corrected QTc interval at screening of > 440 ms. One of the following cardiac rhythm abnormalities documented on the screening ECG: First degree atrioventricular (AV) block as defined by protocol. Type I second degree AV block while awake, type II second degree AV block at any time, complete AV block at any time, or age-adjusted heart rate < 2nd percentile). Use of Tenofovir.
研究者
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