Pharmacokinetics of Maraviroc and Boosted Atazanavir Dual Regimen in Stable HIV-infected Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation
研究概览
简要总结
The purpose of this study is to describe pharmacokinetics of maraviroc (MVC) 300 mg and atazanavir/ritonavir (ATV/r) 200/100 mg QD in HIV-infected stable patients.
详细描述
The rational of this study is to save therapeutic options, toxicity and costs. The available literature shows that antiretroviral regimens that do not include a nucleoside backbone of tenofovir resulted in less bone and kidney toxicity. Atazanavir dosing 200/100 mg qd represents a simplification strategy correlated with virologic efficacy and a reduction of parameters toxicity associated. Maraviroc is suggested as a possible drug associated to PI/r in dual therapies. Even in this case, the available evidence supports the choice of the dosage of 300 mg/day.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years;
- •confirmed HIV-antibodies positivity;
- •signed informed consent;
- •HIV-RNA <20 cp/ml for the last 24 months;
- •no virological failures to PI regimens;
- •no major PI resistance associated mutations;
- •genotypic tropism for CCR5 co-receptor.
排除标准
- •active opportunistic infections or neoplasms;
- •need for drugs with known drug-drug interactions with included drugs;
- •liver cirrhosis;
- •any evidence of tropism for CXCR4 or dual infection;
- •pregnancy;
- •self-reported adherence<90%;
- •HBsAg positivity;
- •detectable HCV RNA.
研究组 & 干预措施
MVC + ATV/r
maraviroc (300 mg tablet, 300 mg per day every 24 hours) + atazanavir/ritonavir (300 and 200 mg capsule, 300 and 200 mg per day every 24 hours / 100 mg capsule, 100 mg per day every 24 hours)
干预措施: maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD) (Drug)
结局指标
主要结局
maraviroc (300 mg, QD) + atazanavir/ritonavir (200/100 mg, QD) pharmacokinetic evaluation
时间窗: within the first 16 weeks after switch
Number of participants with maraviroc Ctrough\>50ng/ml
次要结局
- viral suppression evaluation(week 60)
- CD4 count evaluation(week 60)
- bone density evaluation(week 60)
- bone metabolism markers evaluation(week 60)
- glomerular and tubular renal function evaluation(week 60)
- lipid metabolism markers evaluation(week 60)
- bilirubin evaluation(week 60)
研究者
Giovanni Di Perri
Professor
University of Turin, Italy