ISRCTN51069819已完成2 期
TAILoR - (TelmisArtan and InsuLin Resistance in HIV): A dose-ranging phase II randomised open-labelled trial of telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy (cART)
niversity of Liverpool (UK)0 个研究点目标入组 377 人开始时间: 2012年6月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 377
研究概览
简要总结
2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26474943 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31425580 (added 21/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult, male and female (age 18 or above) HIV-positive individuals receiving antiretroviral therapy containing a boosted protease inhibitor (lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir) and/or efavirenz, for at least 6 months. The backbone can be based on N(t)RTI, raltegravir or maraviroc.
- •Patients on protease inhibitor monotherapy will be included if they meet other criteria.
- •2. Ability to give informed consent
- •3. Willingness to comply with all study requirements
排除标准
- •1. Pre-existing diagnosis of type 1 or 2 diabetes (Fasting glucose > 7.2mmol/L or HbA1c = 6.5% [48 mmol/ml] or abnormal OGTT or random plasma glucose = 11mmol/l)
- •2. Patients known to have consistently low blood pressure (pre-existing hypotension; below a threshold of 100/60 mm Hg)
- •3. Patients with renal disease Estimated Glomerular Filtration Rate(eGFR) <60 in the 6 months preceding randomisation)
- •4. Patients with known untreated renal artery stenosis
- •5. Patients with prior diagnosis of Hepatitis C [a positive polymerase chain reaction (PCR) result in the 6 months preceding randomisation]
- •6. Patients who are on unboosted atazanavir
- •7. Patients who are on/ have been on hormone therapy (eg. growth hormone), anabolics (eg. testosterone) and insulin sensitisers (eg. Metformin) within 6 months preceding randomisation. Patients who are on hormonal contraception are eligible
- •8. Patients who are already on/ have been on other angiotensin receptor blockers (ARBs) and/or angiotensin-converting-enzyme inhibitor (ACE) inhibitors within 4 weeks preceding randomisation
- •9. Those with suspected poor compliance
- •10. Pregnant or lactating women
- •11. Women of childbearing age unless using non hormonal contraception
- •12. Co-enrolment in other drug trials
- •13. Patients who have participated in a trial of an investigative medicinal product (IMP) likely to influence insulin sensitivity, plasma insulin, glucose levels or plasma lipid levels within 6 months preceding randomisation
- •14. For the sub-cohort of patients undergoing MRI/MRS, normal MR exclusion criteria will apply
研究者
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