NCT01236235已完成不适用
A Non Comparative Observational Study to Describe the Duration and Outcome of Treatment in Therapy naïve HIV Positive Patients Initiated on Atazanavir (ATV)/ Ritonavir (RTV)-Based Highly Active Antiretroviral Therapy (HAART) Regimens
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 525 人开始时间: 2011年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 525
- 试验地点
- 1
- 主要终点
- Proportion of patients remaining on ATV-based treatment over time
研究概览
简要总结
The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.
详细描述
Time perspective: Collection of historical data and longitudinal follow up. Patients will be enrolled in 2011/2012 but data will be collected from medical charts from ATV initiation date (Feb 2008 - July 2010) until July 2013 at the latest (if no ATV discontinuation, or death, or lost to follow up).
Non probability sample:
- Specialized HIV management centers will be contacted in order to recruit about 15-20 sites per country.
- Each site will have to enroll an average of 8-12 consecutive patients (min:5; max:30) fulfilling the inclusion/exclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female HIV patients ≥ 18 years old at ATV/RTV initiation treatment date
- •Outpatient seen in routine consultation whatever the reason, between January 1st 2011 and March 31st 2012
- •Commencing an ATV/RTV-based regimen including at least 2 nucleoside reverse transcriptase inhibitors (NRTI) after February 1st 2008 and before July 31st 2010, regardless of the current ARV treatment ongoing at enrollment visit
排除标准
- •Patient exposed to or who began ATV/RTV prior to February 1st 2008, or after July 31st 2010 or without a known start date for ATV/RTV therapy
- •Exposure to more than 4 weeks of any ARV prior to initiation of ATV/RTV treatment
- •Participation in a clinical trial with ATV at the time of or after initiation of ATV/RTV-based regimen
结局指标
主要结局
Proportion of patients remaining on ATV-based treatment over time
时间窗: Up to 5.5 years
Every 6 months from ATV initiation till July 2013 at the latest (maximum follow-up time up to 5.5 years)
次要结局
- Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)(Every 6 months up to 5.5 years)
- Mean change in Cluster of differentiation 4 (CD4) cell count(Every 6 months up to 5.5 years)
- Adverse events (AEs) related to ATV(Every 6 months up to 5.5 years)
- Time to discontinuation of ATV(Every 6 months up to 5.5 years)
- Reasons for ATV discontinuation(Every 6 months up to 5.5 years)
- Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL(Every 6 months up to 5.5 years)
- Mean change in HIV-1 RNA(Every 6 months up to 5.5 years)
- Lipid profile(Every 6 months up to 5.5 years)
研究者
研究点 (1)
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