跨国临床试验（HIV 预防试验网络 052）中未公开的抗逆转录病毒药物使用情况。
Undisclosed antiretroviral drug use in a multinational clinical trial (HIV Prevention Trials Network 052).
机构信息
Department of Pathology.
出版信息
J Infect Dis. 2013 Nov 15;208(10):1624-8. doi: 10.1093/infdis/jit390. Epub 2013 Aug 1.
Abstract
The HIV Prevention Trials Network 052 study enrolled serodiscordant couples. Index participants infected with human immunodeficiency virus reported no prior antiretroviral (ARV) treatment at enrollment. ARV drug testing was performed retrospectively using enrollment samples from a subset of index participants. ARV drugs were detected in 45 of 96 participants (46.9%) with an undetectable viral load, 2 of 48 (4.2%) with a low viral load, and 1 of 65 (1.5%) with a high viral load (P < .0001); they were also detected in follow-up samples from participants who were not receiving study-administered treatment. ARV drug testing may be useful in addition to self-report of ARV drug use in some clinical trial settings.
摘要
HIV 预防试验网络 052 研究纳入了血清学不一致的夫妇。指数参与者感染了人类免疫缺陷病毒，在入组时报告没有进行过先前的抗逆转录病毒（ARV）治疗。使用指数参与者的入组样本的子集进行了回顾性的 ARV 药物检测。在 45 名病毒载量不可检测的参与者（46.9%）、2 名病毒载量低的参与者（4.2%）和 1 名病毒载量高的参与者（1.5%）中检测到了 ARV 药物（P<.0001）；在未接受研究提供的治疗的参与者的随访样本中也检测到了 ARV 药物。在某些临床试验环境中，除了自我报告的 ARV 药物使用情况外，ARV 药物检测可能也很有用。
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