Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Monkeypox viral persistence
研究概览
简要总结
The purpose of this study is to examine the extent of mpox viral spread and immunologic markers in people with advanced HIV. Study findings will enhance knowledge of mpox pathogenesis in severely immunocompromised people, which can inform treatment and prevention of severe illness and deaths associated with mpox in people with advanced HIV.
详细描述
Primary objective:
Describe the relationship between the systemic immunologic response and the persistence and replication competence of mpox virus at rash lesions, in blood, and at mucosal sites over the course of mpox illness among patients with advanced HIV.
Secondary objectives:
- Describe the association between clinical outcomes and virologic and immunologic parameters among patients with severe mpox and advanced HIV.
- Survey for emergence of antiviral drug resistance among MPXV isolates collected over time during mpox illness among patients with advanced HIV.
- Characterize the effects of antivirals to treat mpox and/or HIV infection on virologic and immunologic parameters among patients with mpox and advanced HIV.
- Assess persistence and replication competence of mpox virus in the oropharynx and rectum over the course of mpox illness among patients with advanced HIV.
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
- •Age ≥18 years; AND
- •HIV infection with CD4 count < 200 cells/uL; AND
- •Probable or confirmed mpox (does NOT need to be a new diagnosis); AND
- •Hospitalized while symptomatic from mpox, for reasons other than (or in addition to) infection prevention and control
排除标准
- •Inability of the individual or appropriate proxy to provide informed consent.
- •In the judgment of the clinical treating team, has a medical condition or other factor that might affect their ability to participate in the evaluation.
研究组 & 干预措施
Outpatient
15 outpatients will be recruited from a single pre-determined clinical site (Columbia University)
Inpatient
Up to 85 hospitalized patients will be recruited from other participating clinical sites
结局指标
主要结局
Monkeypox viral persistence
时间窗: While hospitalized, for up to 12 months
Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness
Immune response
时间窗: While hospitalized, for up to 12 months
Cytokine and chemokine profile over the course of illness
Monkeypox viral viability
时间窗: While hospitalized, for up to 12 months
Monkeypox virus viability in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness
次要结局
- Clinical outcome(Up to 12 months)
- Monkeypox virus resistance(While hospitalized, for up to 12 months)