NCT01367210终止4 期
Switch to Darunavir/r + Maraviroc QD in Patients With R5 Tropism by Viral DNA Genotyping With Suppressed Viremia (GUSTA): a Multicenter, Open-label, Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure
研究概览
简要总结
Objectives of the study:
- To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.
- To collect relevant information about the safety, the immunologic and the economic impact of this strategy.
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
- •Patients treated with the same regimen including 3 HAART from at least 4 months
- •Aged 18 years or older
- •Who gave informed consent to the participation to the study
- •With at least two viral load < 50 copies/mL in two consecutive determinations at least 6 months apart (tolerance of two weeks)
- •With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease for at least one year prior to the screening.
- •With R5 tropism by viral DNA genotyping (geno2pheno "clonal")
- •With CD4 cell count nadir>50 cell/mmc or 100 cell/mmc if previous enfuvirtide or integrase inhibitors use
排除标准
- •With at least one major or two minor mutation conferring resistance to darunavir reported in the update list of International AIDS Society - USA , in previous resistance test
- •Previous D/M or X4 viral tropism
- •Previous major clinical toxicities (grade >=3) to the proposed drugs of the study
- •Pregnancy or breast feeding, desire of pregnancy in the short term
- •Past exposure to Chemokine Receptor 5 antagonist
- •HBsAg serostatus
- •Liver cirrhosis of class C (Child-Pugh)
- •Sulpha drug hypersensitivity
- •The presence of major non AIDS-defining diseases that, in the opinion of the investigator, may compromise the retention of the patient in the study for the necessary follow-up period.
- •Estimated glomerular filtration < 30 ml/min (cockroft-Gaut; MDRD formula if black-African or african-american) at screening visit
- •Hypertransaminasemia of grade IV (more than 10 times the upper normal limit) at screening visit
研究组 & 干预措施
MARAVIROC, DARUNAVIR/r
Experimental
Treatment simplification from a "standard" combined antiretroviral therapy including 3 drugs to Maraviroc plus Darunavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy
干预措施: Maraviroc, Darunavir/r (Drug)
current ART with 3 drugs
Sham Comparator
Patients on HAART with three drugs and HIV RNA below 50 copies/mL
干预措施: current antiretroviral therapy with 3 drugs (Drug)
结局指标
主要结局
proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure
时间窗: 48 weeks
次要结局
- Evolution of maraviroc, darunavir, ritonavir plasma concentrations during the 96 weeks(96 weeks)
- Modification of Intima-Media Thickness and Flow Mediated Dilation at 48 and 96 weeks(96 weeks)
- Economic impact of Darunavir/ritonavir+ Maraviroc versus Highly Active Antiretroviral Therapy(96 weeks)
- Evolution of adherence and quality of life after 24, 48 and 96 weeks(96 weeks)
- Proportion of patients with at failure X4 tropism viral tropism (RNA or DNA genotyping)(48 weeks)
- Evolution of CD4 cell- cluster of differentiation 4 cell count during the 96 weeks(96 weeks)
- Evolution of metabolic parameters at 96 weeks(96 weeks)
- Change of the results of neurocognitive tests at 48 and 96 weeks(96 weeks)
- Modification of bone density and subcutaneous fat at 48 and 96 weeks(96 weeks)
- proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 96 weeks at intention-to treat analysis with missing value=Failure(96 weeks)
- Time to virological failure at survival analysis(48 weeks)
研究者
Simona Di Giambenedetto
Dr
Catholic University of the Sacred Heart
研究点 (1)
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