Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV

Conditions
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Monkeypox, HIV Infections, AIDS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatient<br>15 outpatients will be recruited from a single pre-determined clinical site (Columbia University) | |
| Inpatient<br>Up to 85 hospitalized patients will be recruited from other participating clinical sites | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monkeypox viral persistence | Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness | While hospitalized, for up to 12 months | 
| Monkeypox viral viability | Monkeypox virus viability in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness | While hospitalized, for up to 12 months | 
| Immune response | Cytokine and chemokine profile over the course of illness | While hospitalized, for up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Duration of illness from mpox | Up to 12 months | 
| Clinical outcome | Duration of hospitalization with mpox | Up to 12 months | 
| Clinical outcome | Duration of critical illness due to mpox | Up to 12 months | 
| Clinical outcome | Mpox lesion burden | Up to 12 months | 
| Clinical outcome | Mortality | Up to 12 months | 
| Clinical outcome | Characterization of co-infections | Up to 12 months | 
| Monkeypox virus resistance | Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness | While hospitalized, for up to 12 months |