Metabolic Abnormalities, Telmisartan and HIV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Median Change in Visceral Adipose Tissue (VAT) Volume
研究概览
简要总结
This is a research study to see whether fat accumulation either under the skin or in the body's organs, for example, the liver, improves in men and women who take a drug called telmisartan. The investigators will be looking at how the amount of fat in the body changes when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is a medication used to treat blood pressure, but has been shown to decrease fat in the organs in people both with and without high blood pressure. The study involves 8 visits over a period of about 24 weeks.
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
- •HIV positive men and women 18 years and older
- •HIV-1 infection as documented by ELISA and confirmed by Western blot or plasma HIV-1 RNA >2000 on two occasions
- •Documented central fat accumulation
- •HIV RNA documented to be less than 50 copies/mL at screening and undetectable by assay of choice for at least 12 weeks prior to entry
- •Current antiretroviral therapy with a suppressive, highly active antiretroviral regimen.
- •Systolic BP >115mmHg.
- •Ability and willingness to provide informed consent
排除标准
- •Pregnancy (current or within the last 6 months) or nursing
- •Uncontrolled hypertension
- •Prohibited concomitant medications
- •Subjects with untreated hyperlipidemia must be willing to abstain from initiating therapy for the 24 week duration fo the study.
- •Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin sensitizing agents for the duration of the study.
- •Known, untreated renal artery stenosis
- •Unstable coronary artery disease/angina or decompensated congestive heart failure.
- •Any history of intolerance to any member of the angiotensin receptor blocker class of agents.
- •Need for ongoing potassium supplementation.
- •Screening laboratory values as follows ANC (absolute neutrophil count) <750 cells/mm3 Hemoglobin <10 gm/dL ClCr (creatinine clearance)< 30 ml/min (estimated by Cockcroft-Gault equation) AST (aspartate aminotransferase) or ALT (alanine aminotransferase) > 3 x ULN (upper limit of normal)
研究组 & 干预措施
Telmisartan
Telmisartan 40mg po daily for 24 weeks
干预措施: Telmisartan (Drug)
结局指标
主要结局
Median Change in Visceral Adipose Tissue (VAT) Volume
时间窗: Baseline and 24 weeks
VAT volume was quantified at each timepoint by L4-L5 single slice computed tomography
次要结局
未报告次要终点