See Detailed Description
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
研究概览
简要总结
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative subjects.
All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.
详细描述
Safety and Efficacy of an Initial Regimen of Atazanavir (ATV) + Ritonavir (/r) + the Abacavir/Lamivudine Fixed-Dose Combination Tablet (ABC/3TC FDC) for 36 weeks followed by Simplification to Atazanavir with ABC/3TC FDC or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naive HIV-1 Infected HLA-B*5701 Negative Subjects followed by an Optional 60-Week Treatment Extension Phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
Simplification
Atazanavir (ATV) 400 mg QD + abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) QD for 48 weeks followed by optional treatment extension for 60 weeks on the same regimen.
干预措施: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) (Drug)
Continuation
Atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD + abacavir (ABC) 600mg/lamivuidine (3TC )300 mg FDC QD for 48 weeks followed by optional treatment extension for 60 weeks on the same regimen.
干预措施: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) (Drug)
结局指标
主要结局
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
时间窗: Week 84
The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.
次要结局
- Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase(Baseline of Randomized Phase)
- Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit(Week 36)
- Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit(Week 84)
- Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit(Week 144)
- Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit(Week 36)
- Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit(Week 84)
- Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit(Week 144)
- Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36(Week 36)
- Number of Participants Who Met the PDVF Criteria at Week 84(Week 84)
- Number of Participants Who Met the PDVF Criteria at Week 144(Week 144)
- Change From Baseline in HIV-1 RNA at Week 36(Baseline and Week 36)
- Change From Baseline in HIV-1 RNA at Week 84(Baseline and Week 84)
- Change From Baseline in HIV-1 RNA at Week 144(Baseline and Week 144)
- Change From Baseline in CD4+ Cell Count at Week 36(Baseline and Week 36)
- Change From Baseline in CD4+ Cell Count at Week 84(Baseline and Week 84)
- Change From Baseline in CD4+ Cell Count at Week 144(Baseline and Week 144)
- Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36(Baseline through Week 36)
- Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84(Randomization at Week 36 through Week 84)
- Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144(Week 84 through Week 144)
- Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir(Baseline through Week 36)
- Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir(Randomization at Week 36 through Week 84)
- Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir(Week 84 through Week 144)
- Mean Percent Compliance at Week 36(Week 36)
- Mean Percent Compliance at Week 84(Week 84)
- Mean Percent Compliance at Week 144(Week 144)