A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
研究概览
简要总结
The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity.
- •Males and females of childbearing potential must agree to utilize effective contraception methods.
- •Ability to understand and sign a written informed consent form.
排除标准
- •Females who are pregnant or breastfeeding.
- •Participation in any other clinical trial without prior approval from the Sponsor.
- •Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
- •Subjects receiving ongoing therapy with contraindicated drugs.
研究组 & 干预措施
EVG+RTV
EVG 85 mg or 150 mg + RTV + ARV regimen
Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg.
Some participants may receive EVG 300 mg during the course of protocol amendment 2.
干预措施: EVG (Drug)
EVG+RTV
EVG 85 mg or 150 mg + RTV + ARV regimen
Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg.
Some participants may receive EVG 300 mg during the course of protocol amendment 2.
干预措施: RTV (Drug)
EVG+RTV
EVG 85 mg or 150 mg + RTV + ARV regimen
Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg.
Some participants may receive EVG 300 mg during the course of protocol amendment 2.
干预措施: ARV regimen (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event
时间窗: Up to Week 408 plus 30 days
次要结局
- Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality(Up to Week 408 plus 30 days)
- Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events(Up to Week 408 plus 30 days)
- Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality(Up to Week 408 plus 30 days)
- Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384(Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384)
- Incidence of Mortality(Up to Week 408 plus 30 days)