EUCTR2016-002724-83-BE进行中（未招募）1 期
A phase IIa randomized, placebo controlled, double blinded study to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy. - iHIVARNA phase II
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.= 18 years of age;
- •2.Voluntarily signed informed consent;
- •3.Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
- •4.On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
- •5.Nadir CD4+ = 350 cells/µl (up to 2 occasional determinations = 350 cells/µl are allowed);
- •6.Current CD4+ cell count = 450 cells/µl;
- •7.HIV-RNA below 50 copies/mL in the last 6 months prior to randomization, during at least two measurements (occasional so called ‘blips’ = 500 copies/mL are permitted);
- •8.If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (including PrEP).
- •a.For heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; consistent record with condoms; physiological or anatomical sterility (in self or partner) from 14 days prior to the first vaccination until 4 months after the last vaccination.
- •b.For heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Treatment with non-cART regimen prior to cART regimen;
- •2.Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy;
- •3.Non-subtype B HIV infection;
- •4.Active Hepatitis B virus and/or Hepatitis C virus co-infection;
- •5.History of a CDC class C event (see appendix A);
- •6.Pregnant female (screened with a positive pregnancy test), lactating or intending to become pregnant during the study;
- •7.Active malignancy = 30 days (extended period on the clinical assessment of the investigator) prior to screening;
- •8.Active infection with fever (38°C or above) = 10 days of screening and/or first vaccination;
- •9.Therapy with immunomodulatory agents (e.g. systemic corticosteroids), including cytokines (e.g. IL-2), immunoglobulins and/or cytostatic chemotherapy = 90 days prior to screening. This does not include seasonal influenza, hepatitis B and/or other travel related vaccines;
- •10.Congenital, acquired or induced coagulation disorders, such as thrombocytopenia (thrombocytes < 150x109/L) and/or current use of anti-coagulant medication (e.g. coumarins, inhibitors of Xa); Usage of NSAIDs (including acetylsalicylic acid) is allowed, however it is advised to interrupt therapy 10 days ahead of vaccination;
- •11.Usage of any investigational drug = 90 days prior to study entry;
- •12.An employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator
- •13.Any other condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
研究者
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