EUCTR2009-011538-93-IE进行中（未招募）1 期
A prospective, randomised study to access safety, changes in platelet reactivity, plasma cardiac biomarkers and metabolic parameters over 48 weeks in HIV-1 infected subjects undergoing a switch in antiretroviral therapy. - The St. Marys and The Mater Switch Study (SMASH)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •HIV-1 infected males or females
- •Over 18 years of age
- •Signed informed consent
- •Currently receiving a stable antiretroviral regimen comprising of two licensed NRTIs including
- •abacavir and/or didanosine and any licensed boosted protease inhibitor at any dose (excluding
- •tipranavir)
- •Undetectable plasma HIV RNA to less than 50 copies/mL for at least 24 weeks prior to screening
- •Availability of stored plasma with which to perform a tropism assay
- •CCR5 tropic HIV virus based on a tropism assay from a stored plasma sample
- •Willing to continue unchanged, or to modify antiretroviral therapy, in accordance with the
- •randomisation assignment
- •No documented viral resistance to currently licensed HIV-1 protease inhibitors based either on
- •previous HIV-1 genotypic resistance testing or in the judgement of the study investigators
- •No previous exposure to maraviroc or CCR5 receptor antagonists
- •Subjects in good health upon medical history, physical exam, and laboratory testing in the opinion of
- •the investigator
- •Have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface
- •antigen and no serologic evidence of hepatitis C virus infection by a HCV antibody or HCV PCR.
- •Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically
- •sterile or at least two years post menopausal) must avoid becoming pregnancy as follows from
- •screening through completion of the study using one or both of the following methods: barrier
- •contraceptives (condom, diaphragm with spermicide)or IUD PLUS a barrier contraceptive
- •Female subjects of childbearing potential must have a negative pregnancy test.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •failure of current antiretroviral regimen due to virological failure
- •active opportunistic infection, malignancy or significant co-morbidities in the opinion of the
- •investigator
- •pregnancy
- •current prohibited concomitant medication
- •no available stored plasma sample predating their current antiretroviral regimen upon which a
- •tropism assay can be performed
研究者
相似试验
进行中（未招募）
1 期
A prospective, randomised study to assess safety, changes in platelet reactivity, plasma cardiac biomarkers and metabolic parameters over 48 weeks in HIV-1 infected subjects undergoing a switch in antiretroviral therapy. - The St. Marys and The Mater Switch Study (SMASH)HIVEUCTR2009-011538-93-GBImperial College London18
招募中
1 期
Polylaminin for Acute Spinal Cord Injurynspecified injury at unspecified level of cervical spinal cordUnspecified injury at unspecified level of thoracic spinal cordG00-G99RBR-9dfvgpmniversidade Federal do Rio de Janeiro
已完成
不适用
Prospective randomized study of safety outcomes treated with edoxaban in patients with stable coronary artery disease and atrial fibrillatioon-valvular atrial fibrillationJPRN-UMIN000032030ihon university school of medicine200
已完成
不适用
A randomised, open study to assess the safety and efficacy of a new artesunate-mefloquine coformulation with an equivalent dose regimen of the individual drugs for the treatment of acute uncomplicated falciparum malaria (Thailand)Infections and InfestationsMalariaISRCTN10364429Drugs for Neglected Diseases initiative (DNDi) (Switzerland)500
尚未招募
不适用
A comparative study of safety and efficacy of bilastine updosing (40mg) vs combination of bilastine 20mg with levocetrizine 5mg in the treatment of chronic spontaneous urticariaCTRI/2022/10/046449SRM Medical college hospital