Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR
研究概览
简要总结
This study is designed to see how HIV infected patients perform when taking a single fixed dose HIV medication compared to a regimen with multiple tablets. The study is also going to be looking at the differences in complications between the two groups.
详细描述
This is a phase IV retrospective chart review of HIV infected patients in a private Infectious disease practice in West Palm Beach, FL. This chart review will assign patients into one of two groups based on their antiretroviral regimen: single tablet regimen (STR) versus multi tablet regimen (MTR). Up to 650 patient charts will be reviewed but only about 500 patients are needed for statistical analysis.
The primary objective is to look at the proportion of patients with an adherence rate greater than or equal to 95% in subjects prescribed STR versus a MTR.
Secondary Objectives:
- Differences in emergency room visits, hospitalization and readmission in patients taking a STR vs. a MTR
- Proportion of patients with HIV viral load less than 50copies/microliter
- Incidence of new onset or worsening hyperlipidemia in patients taking a STR versus a MTR
- Incidence of acute renal insufficiency
- Compare the absolute CD4 number increase between a STR and a MTR
- Compare monthly copay amounts in patients taking a STR versus a MTR
- Identify the incidence of opportunistic infections in patients taking a STR versus a MTR
研究设计
- 研究类型
- Observational
- 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
- 否
入选标准
- •Male or Female (gender at birth), age 18 years or older
- •Documented HIV-1 infection by western blot or HIV viral load
- •Prescribed antiretroviral therapy, either STR (single tablet regime) or MTR (multi tablet regimen) for at least 6 months
- •Patients should have a minimum of 3 office visits
排除标准
- •Patients who were evaluated in the hospital but never came to the clinic
结局指标
主要结局
Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR
时间窗: 1 year
次要结局
- Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR(2 years)
- Compare proportion of subjects with viral load less than 50 copies/microL(1year)
- Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR(2 years)
- Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR(2 years)
- Compare monthly copay amounts in patients prescribed STR and MTR(1 year)
- compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR(2 years)
- Compare the absolute CD4 number increase between a STR and a MTR(1 year)
研究者
Olayemi Osiyemi MD
President
Triple O Research Institute PA