NCT01230580Unknown4 期
A Randomised Controlled Trial of a Strategy of Switching to Boosted PI Monotherapy Versus Continuing Combination ART for the Long-term Management of HIV-1 Infected Patients Who Have Achieved Sustained Virological Suppression on HAART
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 587
- 主要终点
- Loss of future drug options
研究概览
简要总结
The PIVOT trial aims to determine whether a strategy of switching to PI monotherapy is non-inferior to continuing triple-therapy, in terms of the proportion of patients who maintain all the drug treatment options that were available to them at baseline after at least 3 years of follow-up, and to compare clinical events, safety, toxicity and health economic parameters between the two strategies.
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
- •Vl < 50 for 24 weeks prior to screening CD4 > 100 at screening
排除标准
- •Known major protease resistance mutation(s) documented on prior resistance testing if performed (prior resistance testing is not mandatory for trial participation).
- •Previous change in ART drug regimen for reasons of unsatisfactory virological response (patients who have changed regimen for prevention or management of toxicity or to improve regimen convenience are permitted to enter the trial).
- •Previous allergic reaction to a PI.
- •Patient currently using or likely to require use of concomitant medication with known interaction with PIs.
- •Patient requiring treatment with radiotherapy, cytotoxic chemotherapy, or is anticipated to need these during the trial period.
- •Treatment for acute opportunistic infection within 3 months prior to trial screening.
- •Pregnant or trying to become pregnant at the time of trial entry.
- •History of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments.
- •History of HIV encephalopathy with current deficit >1 in any domain of the Neuropsychiatric AIDS Rating Scale (see Appendix 7).
- •Past or current history of cardiovascular disease, or 10 year absolute coronary heart disease risk of >30%, or risk of >20% if the patient has diabetes or a family history of premature ischaemic heart disease or stroke.
- •History of insulin-dependent diabetes mellitus.
- •Patient currently receiving interferon therapy for Hepatitis C virus infection or planning to start treatment for Hepatitis C at the time of trial entry.
- •Co-infection with hepatitis B, defined as Hepatitis BsAg positive at screening or at any time since HIV diagnosis, unless the patient has had a documented Hepatitis B DNA measurement of less than 1000 copies/ml taken whilst off Hepatitis B active drugs.
- •Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial.
- •Fasting plasma glucose >7.0mmol/L at trial screening.
研究组 & 干预措施
Protease Inhibitor Monotherapy
Experimental
Ritonavir-boosted protease inhibitor
干预措施: Protease Inhibitor (Drug)
Control
Active Comparator
Standard-of-care triple-therapy regimen
干预措施: Standard-of-care Antiretroviral therapy (Drug)
结局指标
主要结局
Loss of future drug options
时间窗: Up to 5 years
The first occurrence of intermediate to high level resistance to any one or more of the standard antiretroviral drugs (limited to licensed drugs in contemporary use) to which the patient's virus was considered to be sensitive at trial entry (i.e. excluding drug resistance that was known to be present on previous resistance testing).
次要结局
- CD4+ count change(Up to 5 years)
- Adverse events(Up to 5 years)
- Confirmed Virological rebound(Up to 5 years)
- Death from any cause(Up to 5 years)
- Serious AIDS-defining illness(Up to 5 years)
- Serious non-AIDS defining illness(Up to 5 years)
- Neurocognitive function change(Up to 5 years)
- Health care costs(Up to 5 years)
- HIV VL in Genital Secretions(Week 96)
- HIV VL in CSF(Week 96)
- Cardiovascular risk change(Up to 5 years)
- Health-related Quality of Life change(Up to 5 years)
研究者
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