Strategic Timing of AntiRetroviral Treatment (START) - START

Regents of the University of Minnesota0 个研究点目标入组 4,600 人开始时间: 2011年2月16日最近更新: 2018年4月30日

试验速览

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•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 (when 4000 participants are enrolled age criteria will change to greater than/equal to 35 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 4590
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•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).

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