Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 482
- 主要终点
- Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
研究概览
简要总结
To evaluate the management of HIV-1 participants treated with antiretroviral combination therapy including the integrase inhibitor raltegravir, all across the country of France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Participant Infected With HIV-
- •Participant for whom raltegravir therapy has been decided and started less than 30 days prior to inclusion in the study.
- •Participant who has received oral and written information about the study and who has agreed to the computer processing of his/her personal data.
排除标准
- •Participant taking part in a clinical trial to assess raltegravir.
- •Participant in whom raltegravir treatment was started more than 30 days ago.
研究组 & 干预措施
Antiretroviral combination therapy including raltegravir
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
干预措施: Raltegravir (Drug)
Antiretroviral combination therapy including raltegravir
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
干预措施: ARV (non-raltegravir) (Drug)
结局指标
主要结局
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
时间窗: Baseline and 24 months after start of raltegravir treatment
Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
时间窗: Up to 25 months after start of raltegravir treatment
Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others.
Percentage of Participants Responding to Treatment: All Treated Participants
时间窗: 24 months after start of raltegravir treatment
Response to treatment was defined as a viral load \<50 RNA copies/mL
Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
时间窗: 24 months after start of raltegravir treatment
Response to treatment was defined as a viral load \<50 RNA copies/mL
Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
时间窗: Baseline and 24 months after start of raltegravir treatment
次要结局
- Number of Participants With at Least One Adverse Event(Up to 25 months after start of raltegravir treatment)