A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change From Baseline in Log HIV Viral Load at 48 Weeks
研究概览
简要总结
This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.
详细描述
We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.
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 must be HIV-1 positive and naïve to HIV therapy.
- •Patients must plan to participate and be available for the trial for the 96-week study period.
- •Patients followed at Thomas Street Clinic.
- •Patients must be over 18 years old.
排除标准
- •Patients must not be pregnant or plan to become pregnant over the 96-week study period.
- •Patients cannot be on a proton pump inhibitor.
- •Patients cannot be undergoing treatment for active tuberculosis.
- •Renal Insufficiency with a creatinine clearance < 50 ml/min/1.73 m2 by the MDRD GFR calculation.
研究组 & 干预措施
Raltegravir
Raltegravir in combination with truvada (tenofovir and emtricitabine)
干预措施: Raltegravir and truvada (Drug)
Atazanavir
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
干预措施: Atazanavir, Norvir and Truvada (Drug)
结局指标
主要结局
Change From Baseline in Log HIV Viral Load at 48 Weeks
时间窗: Baseline and 48 weeks
Change From Baseline in CD4 Count at 48 Weeks
时间窗: Baseline and 48 weeks
次要结局
- Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks(Baseline and 48 weeks)
- Change From Baseline in Homocysteine at 6 Months(Baseline and 48 weeks)
- Change From Baseline in Lipids at 48 Weeks(Baseline and 48 weeks)
研究者
Tanvir K. Bell, MD
Associate Professor
The University of Texas Health Science Center, Houston