EUCTR2014-004331-39-ES进行中（未招募）1 期
HIV Reservoir Dynamics After Switching To Dolutegravir in Patients on a PI/r Based Regimen. A Phase IV Open Randomized Trial - INDOOR
Fundació Vall Hebron Institut de Recerca0 个研究点开始时间: 2014年11月25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
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
- •- Adult patients infected with HIV-1
- •- HIV-RNA <50 copies / mL for ? 1 year with stable regimen of ART (? 3 months) based on a IP / r 2 AN
- •- CD4+ lymphocytes > 200 / mm3
- •- Voluntary signature of informed consent
- •- A woman, may be eligible to enter and participate in the study if:
- •a. no-childbearing potential, defined as post-menopausal (12 months of spontaneous amenorrhea and ? 45 years of age) or physically unable to get pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
- •b. You are of a child-bearing age with a negative pregnancy test on the day of screening and on day 1 and agrees to use one of the following contraceptive methods to prevent pregnancy:
- •- Complete abstinence from penile-vaginal intercourse from 2 weeks before administration of the IP, over the course of the study and for at least 2 weeks after discontinuation of all study drugs;
- •- Double barrier method (male condom / spermicide, condom male / diaphragm, diaphragm / spermicide);
- •- Any intrauterine device (IUD) with published data that show that the expected rate of failure is <1% per year (not all IUDs meet this criterion);
- •- Confirmed male sterilization before to entry of the female subject in the study, and that this man is the only sexual partner for the woman;
- •- Hormonal Contraception Approved
- •- Any other method with published data that show that the expected rate of failure is <1% per year.
- •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 44
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Prior virologic failure with a integrase inhibitor
- •- AIDS defining disease in the last 48 weeks
- •- Glomerular filtration rate <50 mL / min, estimated by the formula CKD-EP*I
- •- ALT ?5 times the upper limit of normal (ULN) or ALT ?3 times ULN and total bilirubin ?1,5 ULN (with> 35% of direct bilirubin) and / or unstable liver disease (presence of ascites, hepatic encephalopathy, hypoalbuminemia, presence of esophageal varices or persistent jaundice) or biliary disorders known excluding Gilbert's syndrome or asymptomatic urolithiasis)
- •- Hepatitis B positive (HBsAg +) or need of treatment HCV during the study.
- •- Subjects with severe hepatic damage (Child Pugh Class C).
- •- Patients unable to understand the study protocol or any other condition that in the investigator's opinion would compromise the protocol compliance.
- •- Pregnant or nursing women
- •- History or presence of allergy to any of the study drugs or their components.
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