NCT00214435Unknown4 期
A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine, Efavirenz and Didanosine Versus Continuation of Current Anti-Retroviral Regimen Delivered at Least Twice Daily
407 Doctors1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- - levels of adherence
研究概览
简要总结
Poor compliance is thought to be a major cause of treatment failure. The TEddI study is a randomised, multi-centre, open-label study in well-controlled treatment-experienced HIV-infected patients to assess compliance with a once-daily regimen of antiretroviral therapy versus continuation of current anti-retroviral regimen delivered at least twice daily.
详细描述
Rationale: 'TEddI' will enable a once-daily treatment strategy to be studied and provide information on effectiveness, patient adherence and quality of life and the tolerability of such regimens.
Hypothesis: The study hypothesis is that an antiretroviral regimen comprising of three agents taken once daily will have higher levels of adherence than a regimen requiring more frequent dosing.
Primary objective: To determine over 24 weeks the levels of adherence in two groups of HIV-infected subjects randomised to receive either a once daily minimum 3-drug regimen or to continue a minimum 3-drug regimen requiring more frequent dosing.
Secondary objectives: The secondary objectives of the study will include:
- To estimate the proportion of patients with treatment failure where treatment failure is defined as:
- HIV-1 RNA viral load of >400 copies/ml on two consecutive occasions more than one month apart, OR
- Discontinuation of treatment for any reason (where subsequent therapy does not comply with the study regimen change guidelines outlined in section 3.3.3)
- Proportion of patients with plasma HIV-RNA less than 50 copies/ml (using an ultrasensitive assay) at 24 and 48 weeks
- Change from baseline in CD4 cell count at 24 and 48 weeks
- Changes from baseline in subjects' quality of life at 24 and 48 weeks
- Changes from baseline based on DASS 21 scores at 24 and 48 weeks
- Incidence and severity of adverse events and abnormal laboratory values (grade 3 & 4) at 24 and 48 weeks
- Proportion of patients remaining on assigned treatment Study Design This is a randomised, open-label, multi-centre, prospective, 48-week study comparing a 3 (or more) drug once-daily antiretroviral regimen with any 3 (or more) drug regimen in which at least 1 drug must be taken at least twice daily.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years or more with laboratory evidence of HIV-1 infection
- •ability to understand and provide written informed consent to participate in the study
- •stable on current ART regimen for at least 3 months prior to screening.
- •plasma HIV-RNA less than 400 copies/ml at the screening visit.
- •women of child bearing potential must have a negative serum or urine β-HCG pregnancy test within 14 days prior to week -4 (assessment of study eligibility)
排除标准
- •virological failure of a proposed Once daily arm medication
- •a serious medical condition which may compromise the subject's safety, including an active AIDS-defining condition within the previous 6 months
- •known toxicities to any of the proposed Once daily arm medications
- •laboratory abnormalities at screening:
- •serum creatinine greater than twice the upper limit of normal (2 x upper limit of normal (ULN))
- •AST, ALT or alkaline phosphatase greater than 5 times the ULN
- •lactate greater than 2.5 x ULN
- •haemoglobin less than 9.5 g/dL
- •women who are pregnant or breast-feeding or who, if of child-bearing potential, are not willing to use adequate contraception (including barrier contraception)
- •patients who in the investigator's opinion are unlikely to complete the study
结局指标
主要结局
- levels of adherence
次要结局
- - proportion of patients with treatment failure where treatment failure is defined
- - HIV-1 RNA viral load of >400 copies/ml on two consecutive occasions more than one month apart, OR discontinuation of treatment for any reason (where subsequent therapy does not comply with the study regimen change guidelines outlined in section 3.3.3)
- - proportion of patients with plasma HIV-RNA less than 50 copies/ml (using an ultrasensitive assay) at 24 and 48 weeks
- - change from baseline in CD4 cell count at 24 and 48 weeks
- - changes from baseline in subjects' quality of life at 24 and 48 weeks
- - changes from baseline based on DASS 21 scores at 24 and 48 weeks
- - incidence and severity of adverse events and abnormal
- - laboratory values (grade 3 & 4) at 24 and 48 weeks
- - proportion of patients remaining on assigned treatment
研究者
研究点 (1)
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