Identification of Broadly HIV-1 Neutralizing Antibodies (bNAb) in HIV-infected Patients in Mbeya, Tanzania.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Broadly HIV-1 neutralizing antibodies (bNAb)
研究概览
简要总结
In natural HIV disease, a small fraction (1-2%) of infected individuals develops exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from these individuals have been shown to be highly active against a broad range of different HIV strains and are therefore called broadly neutralizing antibodies (bNAbs). These antibodies are in fact able to prevent (S)HIV infection in animal models and therefore of great interest for the development of an HIV vaccine. Information of neutralizing antibodies in patients from Africa is still scarce and would be of great value in the development of adapted HIV vaccine strategies in these regions. This study aims to investigate African HIV-infected individuals, who have developed neutralizing antibodies using highly specialized laboratory methodologies.
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
- •Voluntary and informed consent
- •≥18 years of age
- •Documented HIV infection.
- •Willing to consent to active tracing including home tracing
排除标准
- •Deficiency, rendering it difficult, if not impossible, to take part in the study or understand the information provided. This includes alcoholism, drug dependency as well as psychiatric illnesses, suicidal tendencies or any other inability.
- •If within the discretion of the investigator study participation would possibly add not acceptable risk or burden to patient (e.g. significant health deficiencies, social harm)
- •Unlikely to comply with protocol as judged by the principal investigator or his designate
结局指标
主要结局
Broadly HIV-1 neutralizing antibodies (bNAb)
时间窗: December 31, 2018
identify HIV-infected patients which exhibit exceptional HIV-1 neutralizing activity (so called elite neutralizer) and to perform in those patients in depth characterization including: * Detailed analysis of anti-HIV antibody response using single B cell analyis * Isolation of broadly neutralizing anti-HIV antibodies * Testing of in vitro neutralizing activity and binding properties of newly identified bNAbs * Analysis of the antiviral activity and in vivo characteristics of broadly neutralizing antibodies using a HIV-1-infected humanized mouse model
次要结局
- To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers(December 31, 2018)
- To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer(December 31, 2018)
- To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)(December 31, 2018)
研究者
Michael Hoelscher
Professor Dr.
Ludwig-Maximilians - University of Munich