NCT00860977已完成3 期
VALacyclovir In Delaying Antiretroviral Treatment Entry
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 25
- 主要终点
- annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time.
研究概览
简要总结
This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART among HIV infected individuals who neither use nor require HAART, and who have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (aged 18 years or older or as per Local/Provincial Guidelines)
- •documented HIV-1 infection (determined by EIA and Western blot, sites' standard assays are acceptable if approved in advance by the PIs for the study, Dr. Darrell Tan and/or Dr. Sharon Walmsley)
- •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 30 days of initiating trial (baseline visit)
- •does not meet recommendations for initiating ARV therapy according to current guidelines
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily
干预措施: Placebo (Drug)
Valacyclovir
Experimental
oral valacyclovir 500mg twice daily
干预措施: valacyclovir (Drug)
结局指标
主要结局
annual rate of change in CD4 count, calculated as the slope of participants' CD4 count change / time.
时间窗: up to 5 years
次要结局
- Annual rate of change in the CD4 cell count percentage, calculated as the slope of the participants' CD4 count percentage change over time(up to 5 years)
- Log10 plasma HIV viral load at 12, 24 and 36 months of follow-up(up to 5 years)
- Overall quality of life as measured by the MOS-HIV questionnaire at each 6-monthly time point(up to 5 years)
- time from baseline until reaching the composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first.(up to 5 years)
- Frequency of episodes of HSV reactivations at any anatomic site(up to 5 years)
- Treatment-emergent adverse events and laboratory abnormalities (CBC, serum creatinine)(up to 5 years)
- Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV(up to 5 years)
研究者
研究点 (25)
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