Valaciclovir in delaying antiretroviral treatment entry: a multicentre, randomised, placebo-controlled, fully blinded clinical trial

niversity Health Network (UHN) (Canada)0 个研究点目标入组 230 人开始时间: 2009年3月9日最近更新: 2019年5月5日

试验速览

•Current inclusion criteria as of 17/12/2012:
•1. Adult (aged 18 years or older or as per Local/Provincial Guidelines), either sex, with documented HIV-1 infection
•2. Documented HIV-1 infection (determined by EIA and Western blot)
•3. No use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
•4. Anti-retroviral naive (no more than 14 days of total prior anti-retroviral [ARV] exposure)
•5. 5.CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 30 days of initiating trial (baseline visit)
•6. Does not meet recommendations for initiating ARV therapy according to current guidelines
•Initial inclusion criteria at the time of registration:
•1. Adults aged over 18 years, either sex, with documented HIV-1 infection
•2. Documented HSV-2 seropositivity
•3. Maximum of two episodes recurrent symptomatic HSV recurrences per year by self-report
•4. Neither currently using nor anticipated to require chronic anti-HSV therapy during the study
•5. Anti-retroviral naive (no more than 14 days of total prior anti-retroviral [ARV] exposure)
•6. CD4 count within the 400 - 900 cells/mm^3 range (inclusive) on two consecutive occasions, with at least one measurement within 4 weeks of initiating trial
•7. Does not meet recommendations for initiating ARV therapy according to current guidelines

•Current exclusion criteria as of 17/12/2012:
•1. Pregnant or actively planning to become pregnant
•2. Receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)
•3. Have an estimated creatinine clearance less than 30 ml/min
•4. Have another medical condition likely to cause death within 24 months
•5. Enrolled in a therapeutic HIV vaccine or immunotherapy trial
•6. Enrolled in another trial investigating the impact of another intervention on HIV disease progression
•7. 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
•Initial exclusion criteria at the time of registration:
•1. Pregnant
•2. Receiving chemotherapy or chronic steroid therapy
•3. Have an estimated creatinine clearance less than 30 ml/min
•4. Have an active opportunistic infection
•5. Have another medical condition likely to cause death within 24 months
•6. Enrolled in a therapeutic vaccine or immunotherapy trial
•7. Enrolled in another trial investigating the impact of another intervention on HIV disease progression
•8. Fit the phenotype of an HIV elite controller (EC), since the natural history of HIV infection is fundamentally different in such individuals

发起方

niversity Health Network (UHN) (Canada)