A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 5
- 主要终点
- Percentage of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.
详细描述
Key Inclusion Criteria
- Documented HIV RNA >1000 copies/ml
- Subject naïve to ARV. .
- Subject has indication to receive an antiretroviral regimen, based on local guidelines.
- Able to provide informed consent and agree to use a highly effective non-hormonal method of contraception
Key Exclusion Criteria
- Evidence of resistance to Darunavir and/or FTC or 3TC or TDF based on the resistance test
- Patient with chronic hepatitis B
- Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System
- Required use of disallowed concomitant therapies
- Subject with the grade 3 or 4 laboratory abnormalities as defined by DAIDS grading table
Primary Objective
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
Darunavir/ritonavir plus lamivudine
Darunavir/ritonavir 800/100 mg, 1 coformulated tablet QD and lamivudine 300 mg, 1 tablet QD
干预措施: darunavir/ritonavir (Drug)
Darunavir/ritonavir plus lamivudine
Darunavir/ritonavir 800/100 mg, 1 coformulated tablet QD and lamivudine 300 mg, 1 tablet QD
干预措施: Lamivudine (Drug)
Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD)
Darunavir/ritonavir 800/100 mg1 coformulated tablet QD (FDC) plus FTC/TDF 200/300 mg, 1 coformulated tablet QD
干预措施: darunavir/ritonavir (Drug)
Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD)
Darunavir/ritonavir 800/100 mg1 coformulated tablet QD (FDC) plus FTC/TDF 200/300 mg, 1 coformulated tablet QD
干预措施: emtricitabine-tenofovir(FTC/TDF) (Drug)
结局指标
主要结局
Percentage of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48
时间窗: 48 weeks
The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) \<50 c/mL at Week 48 will be assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks).
次要结局
- Percentage of patients with HIV-1 RNA <400 copies/mL at week 24(24 weeks)
- Number and type of resistance mutations in case of virologic failure(from week 24 to week 48)
- CD4+ lymphocyte count and change between baseline (defined as the average between screening and baseline visit values) and weeks 24 and 48(week 24 and 48)
- Frequency, type and severity of adverse events and laboratory abnormalities.(week 24 and 48)
- Clinical disease progression (CDP)(week 24 and 48)
- Changes in quality of life(baseline, week 24 and week 48)
研究者
Pedro Cahn
PhD, MD
Fundación Huésped