Valacyclovir in Delaying Antiretroviral Treatment Entry (VALIDATE) - Valacyclovir in Delaying Antiretroviral Treatment Entry (VALIDATE)

niversity Health Network, Toronto General Hospital0 个研究点目标入组 480 人开始时间: 2012年11月28日最近更新: 2019年4月30日

试验速览

暂无简介。

•-adult (aged 18 years or older or as per Local/Provincial Guidelines)
•-documented HIV-1 infection (determined by EIA and Western blot)
•-documented HSV-2 seropositivity (determined by ELISA during screening
•-no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
•-antiretroviral naïve (no more than 14 days of total prior ARV exposure)
•-CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 4 weeks of initiating trial (baseline visit)
•-does not meet recommendations for initiating ARV therapy according to current guidelines
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 0

•-pregnancy or actively planning to become pregnant
•-receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)
•-Estimated creatinine clearance <30 mL/min
•-Other medical condition likely to cause death within 24 months
•-Enrolled in a therapeutic HIV vaccine or immunotherapy trial
•-Enrolled in another trial investigating the impact of another intervention on HIV disease progression
•-HIV elite controller (EC), phenotypically defined here as documented duration of HIV infection of =5 years, a persistent CD4 cell count =500 cells/mm3, and a persistent plasma HIV viral load of <1000 copies/mL in the absence of antiretroviral therapy

发起方

niversity Health Network, Toronto General Hospital