EUCTR2014-004819-37-IE进行中（未招募）1 期
A multi-centre, prospective, randomised trial of short course alendronate therapy or placebo combined with vitamin D and calcium to prevent loss of bone mineral density in antiretroviral-naïve, HIV-1 infected subjects initiating antiretroviral therapy. - APART
niversity College Dublin0 个研究点目标入组 80 人开始时间: 2015年2月5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
- 80
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
- •- male>30 years old or female>40 years old
- •- HIV-1 antibody positive (no CD4 or HIV RNA criteria)
- •- antiretroviral therapy naïve
- •- be presumed to have achieved peak bone mass
- •- eligible for initiation of antiretroviral therapy in the opinion of the investigator
- •- able to provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Subjects unable to comply with the study protocol or unable to stand/sit upright for at least 30 minutes
- •- history of osteoporosis (defined as hip, femoral neck or spine T score of <-2.5 in men over age >50 or in post-menopausal women)
- •- history of fragility fracture or previous femoral fracture
- •- chronic renal failure estimated by eGFR<60mls/min/1.73m2 at screening using the abbreviated Modification of Diet in Renal Disease (MDRD) equation:
- •- eGFR (ml/min/1,73 m2) = 175 x (CrS) -1,154 x (age)-0,203 x 0,742 (if female) x 1,21 (if black)
- •- hypocalcaemia (corrected calcium <2.2mmol/L) or hypercalcaemia (>2.6mmol/L) at screening
- •- history of Paget’s disease or known primary hyperparathyroidism
- •- previous treatment with or allergy (including hypersensitivity) to bisphosphonates
- •- recent history (past 12 months) of peptic or duodenal ulcers or oesophagitis, aspiration or any other upper gastro-intestinal problem or oesophageal disease that in the opinion of the investigator precludes the use of alendronate
- •- history of dental disease, periodontal disease, poor oral hygiene (as judged in the opinion of the investigator) or recent invasive dental procedures (within the past 3 months) comprising dental extraction and dental prosthetic
- •- current therapy with prescribed calcium or vitamin D preparations (other than over-the-counter multivitamin preparations)
- •- current therapy with aspirin or other regularly prescribed non-steroidal anti-inflammatory drugs
- •- recent significant steroid exposure defined as continual or cumulative use of >5mg prednisolone daily or equivalent for = three months, as per EACS guidelines
- •- for female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study
- •- where in the investigator’s opinion, there is a necessity to initiate ART within the pre-ART study window period (i.e. within the period between screening and ART initiation (approximately 3 weeks)
- •- subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection
- •- any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study
- •- cancer or receiving chemotherapy or radiotherapy
- •- subjects concurrently enrolled in another clinical trial of an investigational medical product
研究者
相似试验
进行中（未招募）
1 期
Alendronate for Prevention of antiretroviral therapy-associated bone loss.Human immunodeficiency virus (HIV) infectionMedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2014-004819-37-DKniversity College Dublin80
进行中（未招募）
1 期
Alendronate for Prevention of antiretroviral therapy-associated bone loss.EUCTR2014-004819-37-GBniversity College Dublin80
已完成
不适用
The clinical and cost-effectiveness of early, goal-directed, protocolised resuscitation for emerging septic shockSevere sepsis/septic shockInfections and InfestationsOther septicaemiaISRCTN36307479Intensive Care National Audit and Research Centre (ICNARC) (UK)1,260
招募中
3 期
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled TrialACTRN12608000053325Australian and New Zealand Intensive Care Research Centre1,600
已完成
不适用
A prospective, multi-centre, randomised trial comparing low-dose aspirin with low-dose aspirin plus low-intensity oral anticoagulation in the primary prevention of thrombosis in patients positive for antiphospholipid antibodiesPrevention of thrombosisCirculatory SystemThrombosisISRCTN81818945Arthritis Research Campaign (ARC) (UK)