A Non-interventional Cohort Study for the Assessment of the Efficacy of RALTEGRAVIR 400 mg Administered Twice Daily in Combination With Other Antiretroviral Drugs to Treat Infection With the Human Immunodeficiency Virus 1 (HIV-1) in Adults and Aging Patients (≥ 50 Years) Under Conditions That Are Representative of the Nationwide Treatment of HIV-positive Patients in Germany
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 主要终点
- Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
研究概览
简要总结
This is an observational, non-comparative, multicenter, open-label study. Participants will be treated with Raltegravir according to standard clinical practice, and monitored over a total period of 96 weeks. In an extension to the study (Amendment 1), a new cohort of aging participants (≥ 50 years) will be recruited and monitored over a total period of 48 weeks. Participants who stop taking Raltegravir before the end of the 96-week period or 48-week period, respectively, will be followed up for 3 months after discontinuing the drug. The primary objective is to determine the proportion of participants with a human immunodeficiency virus (HIV)-1 viral load < 50 copies/mL after 48 weeks of treatment with Raltegravir.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Overall Participants
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
干预措施: Raltegravir (Drug)
Aging Participants
HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
Includes newly enrolled participants ≥ 50 years of age (Amendment Cohort), plus participants from the Initial Cohort who were ≥ 50 years of age at time of recruitment and who completed 48 weeks of treatment (Prolonged Cohort).
干预措施: Raltegravir (Drug)
结局指标
主要结局
Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
时间窗: Baseline and 48 weeks
The percentage of participants with an HIV-1 viral load \<50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
时间窗: Baseline and 48 weeks
The percentage of aging participants (\>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load \<50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined.
次要结局
- Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment(Baseline and 96 weeks)
- HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment(Baseline and 96 weeks)
- Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment(Baseline and 96 weeks)
- HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment(Baseline and 48 weeks)
- Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment(Baseline and 48 weeks)
- Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment(Baseline and 48 weeks)
- Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment(Baseline and 48 weeks)
- Percentage of Aging Participants With Concomitant Diseases at Baseline(Baseline)
- Percentage of Aging Participants Taking Concomitant Medications at Baseline(Baseline)