Strategic Timing of AntiRetroviral Treatment - START

niversity of Minnesota Clinical and Translational Science Institute0 个研究点目标入组 4,625 人开始时间: 2010年9月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•· Signed informed consent· HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed[1] ELISA test; and confirmed by another test using a different method such as a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.· Age >= 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 consecutive CD4+ cell counts > 500 cells/mm3 at least 2 weeks apart within 60 days before randomization

•· 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 · 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· History of decompensated liver disease· 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

niversity of Minnesota Clinical and Translational Science Institute