NL-OMON53114招募中不适用
etherlands Cohort Study on Acute HIV Infection - NOVA study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet the
- •following criteria:
- •-Written informed consent to store samples and perform genetic testing.
- •-Separate written informed consent for invasive sampling procedures:
- •leukapheresis, sigmoidoscopy with biopsies, lymph node biopsy or excision
- •biopsy and lumbar puncture, to store samples and perform genetic testing. - Age
- •>= 18 years
- •- An acute HIV-1 infection, defined according to the modified Fiebig stages
- •I-IV, as described in the previous paragraph (HIV-1 RNA positive and 4th
- •generation ELISA negative or HIV-1 RNA positive and 4th generation HIV ELISA
- •positive with indeterminate Western Blot). Patients in Fiebig stage V and VI
- •will only be included if they have a documented negative HIV test 6 months
- •prior to the (first) positive test.
- •-Female subjects should be willing to use adequate contraception.
- •Chronic control group:
- •-Written informed consent to store samples and perform genetic testing
- •-Separate written informed consent for sampling procedure: leukapheresis (or
- •large blood draw), and/or lymph node excision biopsy, with storage of samples
- •-Age >= 18 years
- •-ART initiated in the chronic infection phase and chronic HIV-infection as
- •confirmed by Western Blot (p31 positive)
- •-Three to 5 years on ART with undetectable viral load and no more than two
- •consecutive blips of >100 HIV RNA copies per mL of plasma in the year before
- •Elite control group:
- •-Written informed consent to store samples and perform genetic testing
- •-Separate written informed consent for sampling procedure: leukapheresis (or
- •large blood draw), and/or lymph node excision biopsy, with storage of samples
- •-Age >= 18 years
- •-Natural control of HIV infection, defined as having 3 undetectable HIV-1 RNA
- •measurements >12 months upon diagnosis or 90% of HIV-1 RNA measurements
- •undetectable >10 years.
排除标准
- •-Contraindication for proposed cART regimen (e.g. impaired renal function) for
- •participants enrolled with an acute HIV infection
- •-Mental disorder that in the view of the investigator would interfere with
- •adherence to the treatment or the study procedures, or the decision to
- •participate in the study.
- •-Immunosuppressive medication or other diseases associated with
- •immunodeficiency.
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