NCT02041247Unknown2 期
Assessment of VAC-3S Therapeutic Properties When Combined With Standard Antiretroviral Therapy (ART) in the Course of HIV-1 Infection. A European, Randomized, Double Blind Placebo-controlled Phase II Study
InnaVirVax24 个研究点 分布在 3 个国家目标入组 90 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 24
- 主要终点
- anti-3S antibodies titer
研究概览
简要总结
The purpose of this study is to evaluate the protective effect of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-1 infection,
- •Adults > 18 and < 60 years of age,
- •Able and willing to comply with the protocol, including availability for all scheduled study visits,
- •Provided a signed written informed consent,
- •Meets study screening physical, medical history and laboratory assessments (defined below),
- •On stable antiretroviral therapy that is consistent with the current standard of care for at least 12 months prior to study screening,
- •Plasma HIV RNA < 50 cps/mL during the previous 12 months,
- •CD4+ T cell count at screening > 200 and < 500 cells/mm3,
- •Adequate hematology, biochemistry, and metabolic blood tests defined as being less than grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1), except for the numeration of CD4 and for the numeration of lymphocytes,
- •Adequate hepatic and renal function defined as being less than Grade 2 according to the Division of AIDS Adverse Events (See Appendix 23.1),
- •Female patients of childbearing age with one documented negative blood pregnancy tests between Screening and Visit 1/Month 0; Female patient of childbearing potential must be receiving two forms of effective contraception and must be willing to use them throughout the study duration. These include oral, transdermal, systemic or implant contraception birth control, intra-uterine devices (IUD), abstinence and double barrier method such as diaphragm with spermicidal gel or other recommended double barrier method,
- •Affiliated with the National Medical Insurance System,
- •Believed by investigator to be able and willing to comply with the requirements of the study protocol and will be available for all scheduled visits at the study site.
排除标准
- •Not meeting all of the inclusion criteria listed above,
- •Administration of any investigational drug or device within 28 days prior to screening,
- •Prior history of an AIDS-defining event in the past 5 years,
- •Active co-infection with either Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any other active viral hepatitis co-infection,
- •Any acute or clinically significant infections within the past month,
- •Known allergy or intolerance to components of VAC-3S as documented through medical records or via patient interview,
- •Chronic active liver disease as documented by any of the following laboratory assessments: ultrasound, clinical assessment, liver biopsy or equivalent non-invasive methods,
- •Receipt of any known vaccinations within the past 1 month prior to screening,
- •Receipt of any agent in the past 12 months that exerts a known immunological effect (e.g. includes but not limited to IL-2, IL-7, growth hormone...),
- •Patients with Insulin Dependent Diabetes Mellitus, patients receiving anti-diabetic treatment, anticoagulants (excluding daily "baby-dose" aspirin) or daily NSAIDs within one week of study enrollment,
- •Receipt of any contraindicated medications listed in Appendix 23.2,
- •History of or active auto-immune disease,
- •Acute or chronic psychiatric conditions which in the opinion of the investigator would need continual psychological support and/or medications incompatible with study participation,
- •Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
- •Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise safety of the patient or the ability to properly administer the study.
结局指标
主要结局
anti-3S antibodies titer
时间窗: From D0 to week 24
次要结局
- tolerance to 6 vaccinations of VAC-3S(From D0 to week 72)
- blood inflammatory marker concentrations(From D0 to week 72)
- immunogenic characteristics of VAC-3S(From D0 to week 72)
- lymphocyte phenotype markers(From D0 to week 72)
- secondary virological effects(From D0 to week 72)
研究者
研究点 (24)
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