'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation
研究概览
简要总结
Dolutegravir (DTG) is a well-tolerated 2nd generation integrase strand transfer inhibitor (INSTI); rilpivirine (RPV) is a well-tolerated non- nucleoside reverse transcriptase inhibitors (NNRTI) and lamivudine (3TC) is a nucleoside reverse transcriptase inhibitors (NRTIs). This study aims to gather the real-world evidence to evaluate effectiveness of the two-drug regimen (2DR). This is a multi-site observational study in subjects who have started and/or who plan to initiate 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor. The study does not require any changes to the routine standard of care that subjects receive. Approximately 500 eligible subjects will be included from potential investigational sites across Europe and data from them will be collected either retrospectively or prospectively.
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
- •HIV positive male or female subjects aged 18 years or over and who have started 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor from 2014 onwards as a first-line treatment among naïve subjects, or a switching option for those with HIV RNA suppression on current treatment (stable switches), or a second-line treatment for those with virological failure on prior treatment.
排除标准
- •No specific exclusion criteria
研究组 & 干预措施
Treatment-naïve participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.
干预措施: Dolutegravir (DTG) (Drug)
Treatment-naïve participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.
干预措施: Lamivudine (3TC) (Drug)
Treatment-naïve participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.
干预措施: Rilpivirine (RPV) (Drug)
Stable switch participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.
干预措施: Dolutegravir (DTG) (Drug)
Stable switch participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.
干预措施: Lamivudine (3TC) (Drug)
Stable switch participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.
干预措施: Rilpivirine (RPV) (Drug)
Prior virological failure participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
干预措施: Dolutegravir (DTG) (Drug)
Prior virological failure participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
干预措施: Lamivudine (3TC) (Drug)
Prior virological failure participants
Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
干预措施: Rilpivirine (RPV) (Drug)
结局指标
主要结局
Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation
时间窗: At Week 24
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 48 Weeks After 2DR Initiation
时间窗: At Week 48
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 96 Weeks After 2DR Initiation
时间窗: At Week 96
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24
时间窗: At Week 24
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 48
时间窗: At Week 48
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 96
时间窗: At Week 96
Number of Treatment-naïve Participants Experiencing Virologic Failure (VF) [Up to 24 Weeks]
时间窗: Up to 24 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 24 weeks of treatment).
Number of Treatment-naïve Participants Experiencing VF [Up to 48 Weeks]
时间窗: Up to 48 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 48 weeks of treatment).
Number of Treatment-naïve Participants Experiencing VF [Up to 96 Weeks]
时间窗: Up to 96 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 96 weeks of treatment).
Number of Stable Switch Participants With VF Within the First 24 Weeks
时间窗: Up to Week 24
VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.
Number of Stable Switch Participants With VF Within the First 48 Weeks
时间窗: Up to Week 48
VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.
Number of Stable Switch Participants With VF Within the First 96 Weeks
时间窗: Up to Week 96
VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 24 Weeks]
时间窗: Up to 24 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 24 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 48 Weeks]
时间窗: Up to 48 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 48 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 96 Weeks]
时间窗: Up to 96 weeks
VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 96 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.
次要结局
- Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks(At Week 24, Week 48 and Week 96)
- Number of Participants With Low Level Viremia(At Week 24, Week 48 and Week 96)
- Time to Virologic Suppression Among Treatment-naïve Participants and Treatment-experienced Viremic Participants, Who Achieved Suppression(Up to Week 96)
- Time to Virologic Failure in the Stable Switch Population(Up to Week 96)
- Number of Participants With Emergent Resistance Mutations Following Virologic Failure (VF) Events(Up to Week 96)
- Number of Participants Who Discontinue Their Baseline 2DR and Who Stable Switch to a Different Regimen While Virologically Suppressed (HIV RNA <50 Copies/mL) at Switch(Up to Week 96)
- Number of Participants Who Discontinue Their Baseline 2DR and Who Switch Following Virologic Failure(Up to Week 96)
- Number of Participants Who Discontinue Their Baseline 2DR Who Are Switching for Safety or Other Reasons(Up to Week 96)
- Number of Participants With AEs and SAEs(Up to Week 96)
- Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts(At baseline (Week 0), Week 24, Week 48 and Week 96)
- CD4/CD8 Ratio(At baseline (Week 0), Week 24, Week 48 and Week 96)