Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 150
- 主要终点
- efficiency (cost-effectiveness)
研究概览
简要总结
The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.
详细描述
Secondary objectives:
- patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)
- Change in the number of CD4 cells at 48 weeks
- Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks
- Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
- Rate of mortality and clinical progression at 48 weeks
- general tolerability and safety: adverse events (AA) and serious AA description
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-negative pregnancy test in women of childbearing age
- •2- stable HIV-1 infection clinically and not take antiretroviral therapy
- •3- viral load HIV <100,000 copies
- •4- CD4 cells >100 cels/mm3
- •5- Glomerular filtration >70mlmin
- •6- have a negative HLA B5701
- •7-.patients should have given informed written consent
- •8- in the opinion of the investigator, be able to follow the design of the Protocol visits
排除标准
- •1-. Patients who had virologic failure with any antiretroviral therapy
- •2- evidence of prior mutations of the study drugs
- •3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study
- •4- contraindication to the drugs study
- •5- any condition that does not allow to ensure the correct compliance to the study
- •6- uncontrolled previous psychiatric illness
- •7- Current or active addiction or alcoholism
研究组 & 干预措施
elvitegravir/cobicistat/emtricitabine/tenofovir
EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day)
干预措施: elvitegravir/cobicistat/emtricitabine/tenofovir (Drug)
darunavir+ritonavir+lamivudine
Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day
干预措施: Darunavir (Drug)
darunavir+ritonavir+lamivudine
Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day
干预措施: Ritonavir (Drug)
darunavir+ritonavir+lamivudine
Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day
干预措施: Lamivudine (Drug)
abacavir/lamivudine+rilpivirine
Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
干预措施: abacavir/lamivudine (Drug)
abacavir/lamivudine+rilpivirine
Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
干预措施: rilpivirine (Drug)
结局指标
主要结局
efficiency (cost-effectiveness)
时间窗: 48 weeks of initiation antiretroviral treatment
Antiretroviral treatment effectiveness defined by the number of patients with \<37 copies/ml viral load at the 48 weeks and the treatment cost defined by the sum of cost ogfthe antiretroviral treatment and all its consequences (adverse effects, changes of pattern study antiretroviral resistance in case of being necessary, days of sick leave by the patient and hospital admission days) that occur in the 48 weeks. The price of the antiretroviral treatment will be defined by Spanish official price.
次要结局
- Change in the number of CD4 cells(48 weeks)
- Change in body composition and mineral density bone lumbar) measurement with DEXA(48 weeks)
- number of patients with virologic response ratio copies mL plasma viral load)(48 weeks)
- Change in markers of renal function filtration rate - eGFR - estimated rate) and renal tubular function(48 weeks)
研究者
Juan A. Arnaiz
Josep Mallolas, Principal Investigator
Hospital Clinic of Barcelona