Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks.
研究概览
简要总结
The main objective is to determine the feasibility of maintaining virologic suppression on standard plasma viral load by dose reduction of ATRIPLA ®.
详细描述
The main objective of this study is to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per week in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.
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
- •Adults (≥ 18 years)
- •HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years.
- •Standard plasma viral load below the limit of detection for at least 2 years.
- •CD4 count above 350/mm3 at the time of the consideration for the study.
- •Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug.
- •Patients should be given written informed consent
- •In the opinion of the investigator, be able to follow the design of the protocol visits
排除标准
- •Patients who have experienced virologic failure prior to any antiretroviral regimen
- •Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine
- •Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study
- •Any contraindication to study drug
- •Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient
- •Uncontrolled preexisting psychiatric illness
- •Any current sign of alcoholism or other drug use.
研究组 & 干预措施
ATRIPLA three times a week.
Atripla (600 mg/200 mg/245 mg) three times a week.
干预措施: ATRIPLA (Drug)
ATRIPLA one time a day.
Atripla (600 mg/200 mg/245 mg) one time a day.
干预措施: ATRIPLA (Drug)
结局指标
主要结局
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks.
时间窗: 24 weeks
Treatment failure defined as any of the following possibilities occurring within the 24-week study framework: virological failure (confirmed plasma viral load 37 copies/ml), discontinuation of the antiretroviral therapy schedule irrespective of the reason, consent withdrawal, lost to follow-up, pregnancy, inability to comply with the study or any other reason that could make the doctor in charge consider the cessation of the study.
次要结局
- The Proportion of Patients With Ultrasensitive Viral Load (<1 Copy / mL) After 24 Weeks.(24 weeks)
- The Change From Baseline to 24 Weeks in the Viral Reservoir in Peripheral Blood Mononuclear Cells(baseline and 6 months)
- Immunological(baseline and 6 months)
- Changes in Plasma Levels of Efavirenz.(baseline and 6 months)
- Changes in Sleep Quality (Pittsburgh Sleep Quality Index).(baseline and 6 months)
- General Safety (Report Adverse Events, Serious Adverse Events and Treatment Discontinuation Due to Adverse Events)(24 weeks)
- Changes in Plasma Levels of Vitamin D.(baseline and 6 months)
- Changes in Lipid Profile.(baseline and 6 months)
- Changes in Estimated Glomerular Filtration Rate.(baseline and 6 months)
研究者
Anna Cruceta
Project manager
Fundacion Clinic per a la Recerca Biomédica