Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Raltegravir area under the curve (AUC) 24 hours and Cmin
研究概览
简要总结
The co-administration of raltegravir with medicinal products that are knouwn to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir. So once daily raltegravir (800 mg QD), instead of twice a day (400 mg BID), could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. In this study, pharmacokinetic data supporting this hypothesis are recovered.
详细描述
Treatment adherence is crucial for the effectiveness of antiretroviral therapy, and, in an attempt to promote treatment adherence by the patients, once daily (QD) regimens are preferred rather than twice daily (BID) regimens.
The dose of 400 mg BID of raltegravir has been recently licensed for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients.
Raltegravir is eliminated mainly by metabolism via uridine diphosphate glucuronyl transferase (UGT1A1)-mediated glucuronidation pathway. Thus, co-administration of raltegravir with medicinal products that are known to be potent UGT1A1 inhibitors, such as atazanavir, may increase plasma levels of raltegravir.
Based on these data, it could be hypothesized that once daily raltegravir (800 mg QD) could be an appropriate therapeutic option in HIV-infected patients also receiving atazanavir-containing antiretroviral regimens. However, pharmacokinetic data supporting this hypothesis are lacking.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65 years old with documented HIV-1 infection.
- •Patients on antiretroviral regimen that includes atazanavir 400mg QD for at least 4 weeks.
- •Complete virological suppression (<50 copies/mL) for at least 12 months.
- •Voluntary written informed consent.
- •Ability of compliance with visit schedule.
排除标准
- •AIDS defining condition within 4 weeks prior to the initiation of the study.
- •Concomitant treatment with ritonavir as well as with inducers (NNRTI, rifampin, carbamazepine, phenytoin, phenobarbital, valproic acid, etc) or inhibitors (probenecid, etc) of the uridine diphosphate glucuronyl transferase within 2 weeks before the screening visit.
- •Concomitant therapy with tenofovir.
- •History or suspected poor adherence to HAART.
- •History of drug allergy to raltegravir
研究组 & 干预措施
1
Addition of raltegravir 800 mg QD to HAART
干预措施: Addition of raltegravir 800 mg QD to HAART (Drug)
结局指标
主要结局
Raltegravir area under the curve (AUC) 24 hours and Cmin
时间窗: Day 10
次要结局
- Adverse events(Baseline (BL), Day 10)
- Adherence(BL, Day 10)