Strategic Timing of AntiRetroviral Treatment (START) - START

Regents of the University of Minnesota0 个研究点目标入组 4,000 人开始时间: 2009年6月18日最近更新: 2012年10月9日

试验速览

暂无简介。

•Signed informed consent, HIV infection documented by plasma HIV RNA viral load, a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry, Age > 18 years, Karnofsky performance score = 80 (an indication that the participant can perform normal activities), Perceived life expectancy of at least 6 months, For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed, Two CD4+ cell counts > 500 cells/mm3 at least 2 weeks apart within 60 days before randomization
•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) yes
•F.1.3.1 Number of subjects for this age range

•Any previous use of ART or IL-2, Diagnosis of any clinical AIDS event before randomization (including esophageal candidiasis and chronic Herpes simplex infection); Presence of HIV progression such as oral thrush, unexplained weight loss, or unexplained fever at randomizaton; Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass grafting, stroke) within 6 months before randomization; Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6 months before randomization; Dialysis within 6 months before randomization; Diagnosis of decompensated liver disease before randomization; Current imprisonment, or compulsory detention (involuntary incarceration) for treatment of a psychiatric or physical illness; Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is required within 14 days before randomization for women of child-bearing potential).

发起方