Non-Interventional Study Of Celsentri® In Treatment Experienced Patients Infected With CCR5 Tropic HIV-1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 主要终点
- Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
研究概览
简要总结
Aim of the study is to gain more knowledge about efficacy of CELSENTRI® in daily clinical practice and obtain information about the quality of life of patients using CELSENTRI®.
详细描述
Non interventional study, inclusion and exclusion criteria defined by the labelling of Celsentri (Maraviroc).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •HIV-1 infection. CCR-5 tropic virus. Therapy experienced patient,
排除标准
- •X4 or D/M tropic virus. Therapy-naive patients.
研究组 & 干预措施
1
Non-Interventional
干预措施: maraviroc (Drug)
结局指标
主要结局
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 3
时间窗: Baseline, Month 3
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 6
时间窗: Baseline, Month 6
Change From Baseline in Log 10 Transformed Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) at Month 12
时间窗: Baseline, Month 12
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 3
时间窗: Baseline, Month 3
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 6
时间窗: Baseline, Month 6
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Counts at Month 12
时间窗: Baseline, Month 12
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 3
时间窗: Month 3
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 6
时间窗: Month 6
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
Number of Participants With Centers for Disease Control and Prevention (CDC) Classification at Month 12
时间窗: Month 12
Participants were classified based on the severity as mild (Category A), moderate (Category B), and severe (Category C).
次要结局
- Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Overall Score at Months 6 and 12(Baseline, Months 6, 12)
- Number of Participants With Human Immunodeficiency Virus (HIV) Response(Month 12)
- Physician's Assessment of Efficacy(Month 12)
- Number of Participants Taking Concomitant Therapy(Baseline, Month 12)