2024-514581-39-00
招募中
1/2 期
Therapeutic vaccination: A Phase I/II Randomized, Placebo-Controlled Trial of ChAdOx1.tHIVconsvX prime-MVA.tHIVconsvX Boost Vaccination Regimen in Early-treated durably-controlling HIV-1 positive Adults. - HIV-CORE 007
Ospedale San Raffaele S.r.l., Ospedale San Raffaele S.r.l.1 个研究点 分布在 1 个国家目标入组 33 人2024年8月5日
概览
- 阶段
- 1/2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Ospedale San Raffaele S.r.l., Ospedale San Raffaele S.r.l.
- 入组人数
- 33
- 试验地点
- 1
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
Raffaele Dell'Acqua
Scientific
Ospedale San Raffaele S.r.l.
入排标准
入选标准
- •a.Male or female, aged 18\-60 years
- •b.Confirmed HIV\-1 seropositive documented
- •c.ART commenced during primary HIV infection, as defined by Fiebig stage
- •d.Plasma HIV\-RNA \< 50 copies/ml for at least 24 months
- •e.Stable ART regimen \= 3 months
- •f.Willing and able to give written informed consent for participation in the study
- •g.Willing and able to adhere to an effective ART regimen for the duration of the study
- •h.CD4\+ T cell count \>\= 500 cells/mm3 at screening
- •i.No new AIDS\-defining diagnosis or progression of HIV\-related disease
- •j.Haematological and biochemical laboratory parameters as follows:
排除标准
- •a.Confirmed HIV\-2 seropositive
- •b.Women who are pregnant or breastfeeding
- •c.Participation in another clinical trial within 12 weeks of study entry
- •d.Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both active and chronic hepatitis C virus infection, with detectable virus RNA, and syphilis
- •e.History of systemic cancers, such as Kaposi’s sarcoma and lymphoma, or other virus\-associated malignancies and/or history of AIDS\-defining illness according to Centers for Disease Control and Prevention criteria
- •f.Resistance to two or more classes of antiretroviral drugs
- •g.History of cardiovascular event or at high risk of an event (eg, atherosclerotic cardiovascular disease score \>15%)
- •h.History of CD4\+ T cell nadir \<200 cells per µl during chronic stages of infection
- •i.Advanced non\-alcoholic fatty liver and advanced nonalcoholic steatohepatitis, if evidence for substantial fibrosis (fibrosis score \=F2\) or evidence of cirrhosis
- •j.HIV\-related kidney disease or moderate\-to\-severe decrease in estimated glomerular filtration rate (\<45–60 ml/min/1·73 m²)
结局指标
主要结局
未指定
研究点 (1)
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