A Randomized Controlled Trial of a Weekly Schedule of Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment (5/2 Intermittent Treatment Schedule) Versus Continuous Treatment in Individuals With Virologic Suppression on This Combination
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)
研究概览
简要总结
For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.
详细描述
The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a larger study based on the results of our successful pilot study using the same protocol. The 48 week, phase IV trial addresses the issues of the high cost of HIV treatment, adherence problems associated with daily treatment, and cumulative toxicities. Virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will be measured. Subjects will have to be seen at CRI for 6 visits after randomization. Subjects randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load remains undetectable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •CD4 count > or = 200
- •Viral load < 50
- •Treatment with a regimen containing efavirenz and tenofovir and lamivudine or emtricitabine for at least 90 days prior to screening
排除标准
- •Detectable HIV RNA on an ultrasensitive assay within the 90 days preceding screening
- •Prior evidence of intermediate or high level resistance to efavirenz, tenofovir or cytidine analogues
- •Hepatitis B infection
研究组 & 干预措施
Control Arm with Week 24 Crossover
Subjects randomized to the control arm will remain on daily dosing of the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily for 24 weeks. After 24 weeks of daily therapy subjects on this arm may be eligible to cross over to the experimental arm regimen of the coformulated single tablet of 600 mg efavirenz +300 mg tenofovir df +200 mg of emtricitabine on the 5/2 intermittent dosing treatment schedule for the remainder of the study.
干预措施: Intermitent Dosing (Drug)
5/2 Intermitent Treatment Arm
Subjects randomized to the 5/2 intermittent dosing treatment schedule regimen will be prescribed the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily, for 5 consecutive days per week followed by 2 days off of these medications, 600 mg efavirenz, 300 mg tenoforvir dt and 200 mg emtricitabine, for 48 weeks.
干预措施: Intermitent Dosing (Drug)
结局指标
主要结局
Percentage of Participants Who Maintained Virologic Suppression (Less Than 50 RNA Cps/ml)
时间窗: 24 weeks
Percentage of Participants maintaining full Virologic Suppression (less than 50 RNA cps/ml)
次要结局
- Absolute Number of Virological "Blip" Events Occurring Over 24 Weeks(Baseline to week 24)
- Quality of Life(4 weeks)
- Self-reported Adherence Summary in Both Arms(4, 12 and 24 weeks)
- Deviation From FOTO Schedule by One Extra Dose(4, 12, 24 weeks)
- Trough Blood Levels of Efavirenz in Both Arms(12 or 60 hours)
- Mean CD4+ T-cell Count Increases From Baseline to Week 24.(Baseline to Week 24)