Characterization of Acute and Recent HIV-1 Infections in Zurich. a Long-term Observational Study: the Zurich Primary HIV Infection Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Evaluation of early events between virus and host to better understand HIV-pathogenesis during the early course of HIV infection.
研究概览
简要总结
Aim of the study: To study and to describe factors which could influence the course of primary HIV infection (PHI) and factors that in turn could be influenced through PHI.
In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies.
详细描述
The ZPHI is a longitudinal, observational, multi-center study. The ZPHI study started in 2002: The first patient visit (FPFV) was in January 2002. Since then, we continuously enrolled patients fulfilling the inclusion criteria. Because the ZPHI is an observational, longitudinal study and the HIV epidemic in Switzerland evolves continuously a clear study end point is not possible. We plan to critically revise the current protocol every 5 years and at that point, also evaluate whether the study should be continued.
This study so far has been highly successful in the recruitment of patients with a PHI. To date we have enrolled more than 480 patients with a documented PHI since project start in 2002.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •A) acute HIV-1 infection, defined as:
- •negative or evolving immunoblot in the presence of positive p24 Ag and/or detectable plasma HIV-1 RNA and/or
- •documented HIV seroconversion within 90 dayswith or with-out symptoms and/or clinical signs of PHI (e.g. acute retro-viral syndrome).
- •B) recent HIV-1 infection, defined as:
- •documented seroconversion of more than 90 days but within 180 days and/or
- •evolving immunoblot after unambiguous transmission risk (e.g. iv drug use, sexual contact) within 180 days and/or
- •documented HIV infection and unambiguous transmission risk (iv drug use, sexual contact) within 180 days and/or
- •documented HIV infection and possible transmission risk (iv drug use, sexual contact) within the last 180 days after infection AND < 0.5% fraction of ambiguous nucleotides
排除标准
- •Documented HIV infection, however, established diagnosis more than 180 days after presumed date of infection.
结局指标
主要结局
Evaluation of early events between virus and host to better understand HIV-pathogenesis during the early course of HIV infection.
时间窗: 30 years
The enrolment and the longitudinal follow up of patients with a documented PHI will allow us to study early events between virus and host and to better understand HIV-pathogenesis during the early course of HIV infection. We aim to expand the established biobank in order to collect samples from patients with an acute or recent HIV infection: For the biobank, we will collect blood samples which are obtained in addition to the routinely collected clinical samples. This concerns ETDA blood samples, initially collected every 3 months until week 48, followed by every six months until week 240 and thereafter once yearly from week 240 onwards. Moreover, a stool sample will be collected and stored for research purposes only. In addition, we will store routinely collected CSF, STI swabs (rectal, virginal, urethral, pharyngeal), urethral swabs, stool samples and in case of high-resolution anoscopy also rectal biopsy materialin the biobanks of the accoding institutes.
次要结局
- Systematic Collection and Analysis of Personal Health and Clinical Data(30 Years)
- Systematic Assessment of PHI to Identify Atypical Presentations(30 Years)
- Systematic Screening for Sexually Transmitted Infections (STIs)(30 Years)
- Identification of Transmission Networks for HIV and Acute Hepatitis C(30 Years)
- Investigation of Viral Factors in HIV-1 Pathogenesis(30 Years)
- Analysis of Biological Characteristics of Transmitted Viruses(30 Years)
- Study of HIV-Specific Immune Responses and Innate Immune System Factors(30 Years)
- Genetic Studies Using Next-Generation Sequencing to Investigate Traits Linked to HIV Progression(30 Years)