EUCTR2010-022120-72-GB进行中（未招募）1 期
The metabolic impact of Darunavir/ritonavir maintenance monotherapy after successful viral suppression with standard Atripla in HIV-1-infected patients (MIDAs). - MIDAS
Guy's & St. Thomas' NHS Foundation Trust0 个研究点目标入组 70 人开始时间: 2010年11月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males and Females aged between 18 and 65
- •2.Documented Positive HIV 1-antibody test
- •3.Plasma HIV RNA <100 copies/ml and on Atripla for at least six months prior to study start
- •4.Agreeable NOT take vitamin D supplements for the duration of the study
- •5.Ability to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Pregnant or breast feeding
- •Patient unlikely to comply with protocol, and in particular adhere to therapeutic regimen
- •Hep B sAg positive at screening or prior to starting antiretroviral therapy (ARV)
- •Known active HCV
- •Documented hepatic impairment
- •Major protease inhibitor mutations likely to significantly impact on the efficacy of darunavir/ritonavirDocumented osteoporosis requiring treatment
- •Diabetes mellitus
- •Received vitamin D supplementation within 3 months of screening visit.
- •Women of childbearing potential, or sexually active males with female partners of childbearing potential unwilling to use barrier method contraception (condoms)
- •Hypersensitivity to any of the active substances and excipients
- •Current or likely use of any of the following substances would exclude an individual from the trial: rifampicin, antiarrhythmics (amiodarone, bepridil, encainide, flecanide, propafenone, quinidine, systemic lidocaine), alfuzosin, analgesics (Pethidine, piroxicam, propoxyphne),antihistamines (astemizole, terfenadine), Antibiotics (fusidic acid), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), antipsychotics/neuroleptics (Clozapine, pimozide, sertindole), sedatives/hypnotics (Clorazepate, diazepam, estazolam, flurazepam, triazolam and midazolam administered orally) and HMG-CoA reductase inhibitors (simvastatin and lovastatin), PDE5 inhibitor (Sildenafil), St. John’s Wort and/or any CYP3A inhibitors.
- •Individuals experiencing side effects from their current regime will not be excluded from analysis.
- •Documented HIV-2 antibody test
研究者
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