A Single Arm Study to Assess the Sustained Virological Suppression and Improvement of Treatment-emerged Adverse Events of Switching to Raltegravir in Stable HIV-infected Patients on Ritonavir-boosted Protease Inhibitor Regimen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 7
- 主要终点
- The proportion of patient-reported clinical adverse events
研究概览
简要总结
Switching from the ritonavir-boosted protease inhibitor component to raltegravir in stable HIV-infected adult patients receiving combination therapy will demonstrate improved clinical tolerability or lipid profiles with sustained plasma virological response (<50 copies/ml).
详细描述
A. Objectives To compare the treatment-emerged AEs and virological suppression after switch to raltegravir-based therapy in stable HIV-infected patients who receiving ritonavir-boosted protease inhibitor antiretroviral regimen
Primary endpoints:
- The changes in overall incidence and severity of patient-reported clinical adverse events (based on "symptom distress module) after switch to raltegravir-based therapy.
Secondary endpoints:
- The proportion of patients who are free of "virological failure" at week 48 after switch
- The change from baseline in CD4 cell counts at week 48 after switch
- The change in quality of life by assess the changes in the domain scores of MOS-HIV questionnaire at baseline and different study time points.
- The changes in laboratory adverse event, e.g., the mean percent changes from baseline to 48 weeks in plasma lipid profile (total cholesterol, LDLCholesterol, HDL Cholesterol, triglycerides) after switch
- The proportion of patients who are free of "treatment failure" at week 48 after switch
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are infected with HIV-1
- •Ages at least 20 years
- •Patients are currently receiving a ritonavir-boosted PI-based regimen, including lopinavir, atazanavir, or darunavir, plus at least 2 antiretroviral agents (NRTIs)
- •Patient complained of treatment-emerged clinical adverse events or abnormal lipid profile
- •Patients with plasma HIV-1 viral RNA below 50 copies per ml for at least 6 months
排除标准
- •Patient with known history of contraindication or hypersensitivity to any component of the study regimen
- •Patients with acute or decompensated chronic hepatitis in the previous 6 months
- •Patients with chronic hepatitis and serum aminotransferase concentrations are more than 5 times the upper limit of the normal range
- •Patients with renal insufficiency (patients need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
- •Current alcohol or substance abuse (patients receiving methadone for the management of withdrawal symptoms due to substance abuse are allowed )
- •Patients have failed previous regimens (prior to starting the current 2NRTI+PI/r regimen they are currently on)
- •Patient's viral load have not been consistently <50 copies per ml for 6 months or longer.
- •Patients initiated lipid lowering agents during the preceding 3 months
- •Patients with any medical disorder or history of any illness which, in the opinion of the investigator, that the use of study medications is contraindicated or might confound the results of the study or pose additional risk in administering study drugs to the patient
- •Pregnant, wish to become pregnant during the study period or breastfeeding women
- •Patients who are lack of expectation to maintain assigned study medication during study period
- •Patients who have received therapy with investigational drugs in the previous 3 months
研究组 & 干预措施
Raltegravir switch
Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
干预措施: Raltegravir switch (Drug)
结局指标
主要结局
The proportion of patient-reported clinical adverse events
时间窗: Week 4, 12-16, 28-32, 48
The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 4 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 12-16 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 28-32 weeks, The proportion of patient-reported clinical adverse events in total and by severity (based on symptom distress module) at 48 weeks
次要结局
- The proportion of patients who are free of "virological failure"(Week 4, 12-16, 28-32, 48)
- The change from baseline in CD4 cell counts(Week 4, 12-16, 28-32, 48)
- the change from baseline in life quality (based on the MOS-HIV questionnaire)(week 12-16, 48)
- The percent changes from baseline in plasma lipid profiles (total cholesterol, LDL Cholesterol, HDL Cholesterol, triglycerides)(Week 4, 12-16, 28-32, 48)
- The proportion of patients with treatment failure(Week 4, 12-16, 28-32, 48)