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临床试验/NCT02295384
NCT02295384已完成不适用

Use of Concomitant Medications in HIV-1 Infected Patients in a Large Community Practice in Sydney, Australia

Holdsworth House Medical Practice1 个研究点 分布在 1 个国家目标入组 1,104 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,104
试验地点
1
主要终点
Types of concomitant medications used in patients with HIV-1 infection

研究概览

简要总结

For the majority of patients, management of HIV-1 infection involves effective and well tolerated antiretroviral therapy with simplified pill load and dosing, exemplified by the availability of single tablet regimens (STRs) with single tablet once daily dosing. STR therapy has been shown to improve adherence and reduce hospitalisations (Cohen et al., 2013; Sax et al., 2012).

However, the aging of the HIV cohort in Australia and globally has raised issues of increasing co-morbidities and consequent polypharmacy to manage these (Jansson & Wilson, 2012; Edelman et al., 2013).

Polypharmacy may not only impact on adherence, but also increases the potential for drug-drug interactions (Holtzman et al., 2013).

Stribild, a highly effective STR, contains cobicistat to boost the levels of the component integrase inhibitor, elvitegravir. Cobicistat does not have antiretroviral activity, but acts by inhibiting Cyp3A4 of the cytochrome p450 metabolic pathway. Other drugs metabolized via this pathway may be affected by this drug-drug interaction (Rogatto et al., 2014). Additionally there is evidence of increased risk of nephrotoxicity with co-administration of tenofovir and non-steroidal anti-inflammatory medication (NSAIDS) (Marcotte et al., 2008).

Data on use of concomitant medications in Australian patients with HIV is sparse. This study aims to determine, in a large caseload community HIV practice, the use of concomitant medications in HIV, patient pill load and dosing frequency, and potential drug-drug interactions with stribild.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented HIV-1 infection
  • Attendance during the study period for at least 2 visits >3 months and <12 months apart with measured laboratory virological or immunological markers (either on-site or at a co-management site).

排除标准

  • Attendance by patient with HIV infection who does not have laboratory markers of HIV viral load or CD4 count
  • Incomplete/inaccessible patient records

结局指标

主要结局

Types of concomitant medications used in patients with HIV-1 infection

时间窗: 9.5 years

Quantity of concomitant medications used in patients with HIV-1 infection

时间窗: 9.5 years

The pill burden of concomitant medications for patients with HIV-1 infection

次要结局

  • Frequency of drug dosing(9.5 years)
  • Total pill load in patients with HIV(9.5 years)
  • Use of concomitant medications that could have potential drug-drug interaction with stribild (co-formulated elvitegravir/cobicistat/tenofovir/emtricitabine)(9.5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Mark Bloch

Principle Investigator

Holdsworth House Medical Practice

研究点 (1)

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