T-cell Responses to Concurrent HIV and Herpesvirus Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- HIV-1 specific TCR repertoire: Change in Simpson's diversity index over time
研究概览
简要总结
This is a research study in which we are trying to discover new information about how HIV and herpes viruses interact with the immune system. The goal of the study is to learn more about how T-cells in your immune system respond to and fight off long-term (chronic) viruses, in order to improve medical care in the future.
详细描述
HIV-uninfected & HIV-infected participants who enroll on this study will be asked to provide blood samples for 18 months. These samples will be used to assess T-cell responses and presence of herpesvirus(es).
Primary Objective
Characterize phenotypic and functional features, including TCR repertoires of HIV-specific CD8 T-cell responses and exhaustion in HIV-positive humans with and without concomitant herpesvirus infections.
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
- •Criteria • Participant is greater than or equal to 18 years of age.
- •Group 1 (HIV Uninfected) Only
- •Participant is HIV negative per antibody screen conducted on premises
- •Participant is enrolled on HPTN 083 study (receiving HIV-PrEP) (see Recruitment and Screening).
- •Group 2 (HIV Infected) Only
- •Participant has initiated ART therapy as a patient at St Jude Children's Research Hospital
- •*Note: participants will be allowed to continue on study and have data analyzed regardless of presence of detectable HIV or CD4+ counts.
- •a) Newly diagnosed HIV
- •Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis within 90 days prior to enrollment
- •b) Prolonged HIV
- •Participant is HIV-1 positive per medical record documentation or positive antibody screen conducted on premises, with initial diagnosis more than 365 days prior to enrollment
排除标准
- •Participant is unable or unwilling to provide informed consent.
- •If female of child bearing potential, participant has a positive urine pregnancy test at screening. Note: if participant becomes pregnant while on study, they may not continue on study.
- •Concurrent enrollment on a research study or receiving treatment for concurrent medical diagnosis with any of the following interventions which may impact study outcomes: high dose or prolonged steroids, chemotherapy to treat malignancy, radiation therapy, biologic pharmaceutical treatments that induce immunosuppression.
- •If in the opinion of the investigator, participation in the blood draw would endanger the health of the participant.
- •Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week).
结局指标
主要结局
HIV-1 specific TCR repertoire: Change in Simpson's diversity index over time
时间窗: 0, 6, 12 and 18 months (+/- 30 days for all time points after 0).
using separated PBMCs, HIV-1 specific T-cells will be labeled with major histocompatibility complex (MHC) I tetramers previously described to be specific for HIV-1 \[14-18\]. Labeled cells will be subjected to flow cytometry for identity confirmation via established antibody cell marker staining, counting and sorting into single cells. The TCR genes of the individually sorted HIV-1 tetramer positive T-cells will then be sequenced, establishing a repertoire of TCR sequences. Diversities of the TCR gene repertoires obtained from each study group will be assessed using the established algorithm for Simpson's diversity index \[9\].
次要结局
- HIV control: HIV viral load(0, 6, 12 and 18 months (+/- 30 days for all time points after 0)
- T-Cell exhaustion: binary value (Exhausted/not exhausted)(0, 6, 12 and 18 months (+/- 30 days for all time points after 0)
- Herpesvirus specific TCR repertoire: Change in Simpson's diversity index(0, 6, 12 and 18 months (+/- 30 days for all time points after 0).)
- Presence of herpesvirus infections: IgM and IgG levels(0, 6, 12 and 18 months (+/- 30 days for all time points after 0)
- HLA typing(baseline)