EUCTR2015-002234-53-GB进行中（未招募）1 期
Early administration of anti-latency reversing therapy and broadly neutralizing antibodies to limit the establishment of the HIV-1 reservoir during initiation of antiretroviral treatment - a randomized controlled trial (eCLEAR) - eCLEAR
Department of Infectious Diseases, Aarhus University Hospital0 个研究点目标入组 60 人开始时间: 2018年3月13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
- 60
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
入选标准
- •- Documented HIV-1 infection
- •-No current or prior antiretroviral therapy
- •-Age >18 years
- •-CD4+ T-cell count >200/µL on last visit prior to study entry
- •-Able 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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •-Current immunosuppressive therapy
- •-Ongoing AIDS-defining condition
- •-Pregnancy as determined by a positive urine beta-hCG (if female).
- •-Participant unwilling to use reliable contraception methods for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female).
- •-Currently breast-feeding (if female).
- •-Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia).
- •-Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood
- •-Unable to follow protocol regimen
研究者
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