Phase II Trial Assessing the Efficacy of a Reduced Dose Strategy of Darunavir to 400 mg/d in HIV-1 Infected Patients Virologically Suppressed Under a Once Daily Regimen Including Darunavir 800 mg/d and Two Nucleoside Reverse Transcriptase Inhibitors (NRTI), to Maintain the Viral Load Lower Than 50 Copies / mL at 48 Weeks of Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of patients with therapeutic success, defined as no virological failure
研究概览
简要总结
Phase II trial assessing the efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
详细描述
Principal objective: To evaluate the proportion of subjects virologically suppressed at week 48 (viral load=VL ≤ 50 cp/mL) under a tri-therapy containing the darunavir at the dose of 400 mg/d.
Secondary objectives: To evaluate between baseline and week 48: proportions of subjects: in virological failure (confirmed VL > 50 cp/mL) confirmed by a 2nd measure made between 2 to 4 weeks, with VL ≤ 50 cp/mL and between 20 and 50 cp/mL, emerging drug resistance if virological failure, CD4 cell count evolution, HIV DNA evolution, morphological and glucido-lipid parameters modifications, digestive treatment tolerance , adherence to treatment, overall cost of antiretroviral therapy, factors associated to virological failure including baseline and nadir CD4 cell count, darunavir plasma level, baseline HIV DNA viral load.
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
- 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-1 infected adults,
- •age ≥ 18 years,
- •with a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI (≥ 6 months),
- •virologically controlled (VL ≤ 50 cp/ml,
- •≥ 1 year,
- •at least 2 VL spaced at least 3 months apart in the last 12 months) CD4 count ≥ 300/mm3 ≥ 6 months,
- •virus sensible to darunavir and the used NRTI (pretreatment resistance genotypic test available) and
- •with no history of virological failure (VL > 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
- •no current opportunistic infection,
- •renal clearance ≥ 60 mL/min if tenofovir is used,
- •transaminases (SGOT, SGPT) plasma levels < 2N,
- •hemoglobin > 11 g/dL,
- •platelets count > 150 000/mm3,
- •negative pregnancy test in women with childbearing potential,
- •informed written consent signed by both the investigator and the subject,
- •national insurance scheme (article L1121-11 of the French Public Health code),
- •no participation to any other clinical trial
排除标准
- •HIV-2 infection,
- •current antiretroviral therapy different from a once-a-day ritonavir-boosted darunavir 800mg/j containing regimen plus 2 NRTI,
- •virus genotypically resistant to darunavir and the used NRTIs,
- •history of virological failure (VL > 200 cp/mL after ≥ 6 months under PI and/or used NRTI),
- •irregular follow-up and/or history of lack of adherence to ART ≤ 12 months,
- •current pregnancy,
- •current opportunistic infection,
- •associated treatment containing one or more drugs interacting with hepatic cytochromes,
- •any addictive behaviors (alcohol consumption, drugs …) likely to jeopardize the safety of the treatment and / or patient compliance and adherence to the trial.
研究组 & 干预措施
Darunavir 400mg/d
Tri-therapy containing Darunavir at dose of 400 mg/d.
干预措施: Darunavir (Drug)
结局指标
主要结局
Proportion of patients with therapeutic success, defined as no virological failure
时间窗: Week 48
Virological failure is defined as confirmed VL \> 50 cp/mL and no change of the strategy
次要结局
- Emerging drug resistance if virological failure(Week 48)
- Treatment Digestive tolerance(Week 48)
- Proportions of patients with VL < 50 cp/ml(Week 12, Week 24, Week 36, Week 48)
- Change from baseline in blood CD4 cell count at week 12, week 24, week 36 and week 48(Week 12, Week 24, Week 36, Week 48)
- Change from baseline in blood HIV DNA at week 48(Week 48)
- Treatment adherence(Week 48)
- Proportions of patients with virological failure (confirmed VL > 50 cp/ml)(Week 48)
- Proportions of patients with VL between 20 and 50 cp/ml(Week 12, Week 24, Week 36, Week 48)
- Change from baseline in blood lipids at week 24 and week 48(Week 24 and Week 48)
- Change from baseline in glucose at week 24 and week 48(Week 24 and Week 48)