VIRISMAP: Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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:
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Describe the association between clinical outcomes and virologic and immunologic parameters among patients with severe mpox and advanced HIV.
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Survey for emergence of antiviral drug resistance among MPXV isolates collected over time during mpox illness among patients with advanced HIV.
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Characterize the effects of antivirals to treat mpox and/or HIV infection on virologic and immunologic parameters among patients with mpox and advanced HIV.
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Assess persistence and replication competence of mpox virus in the oropharynx and rectum over the course of mpox illness among patients with advanced HIV.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Monkeypox viral persistence [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
- Monkeypox viral viability [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
- Immune response [While hospitalized, for up to 12 months]
Cytokine and chemokine profile over the course of illness
Secondary Outcome Measures
- Clinical outcome [Up to 12 months]
Duration of illness from mpox
- Clinical outcome [Up to 12 months]
Duration of hospitalization with mpox
- Clinical outcome [Up to 12 months]
Duration of critical illness due to mpox
- Clinical outcome [Up to 12 months]
Mpox lesion burden
- Clinical outcome [Up to 12 months]
Mortality
- Clinical outcome [Up to 12 months]
Characterization of co-infections
- Monkeypox virus resistance [While hospitalized, for up to 12 months]
Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years; AND
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HIV infection with CD4 count < 200 cells/uL; AND
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Probable or confirmed mpox (does NOT need to be a new diagnosis); AND
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Hospitalized while symptomatic from mpox, for reasons other than (or in addition to) infection prevention and control
Exclusion Criteria:
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Inability of the individual or appropriate proxy to provide informed consent.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centers for Disease Control and Prevention | Atlanta | Georgia | United States | 30333 |
Sponsors and Collaborators
- Centers for Disease Control and Prevention
Investigators
- Principal Investigator: Agam Rao, MD, Centers for Disease Control and Prevention
- Study Director: Irini Sereti, MD, National Institutes of Health (NIH)
- Study Director: Faisal Minhaj, Pharm.D., Centers for Disease Control and Prevention
- Study Director: Shama Cash-Goldwasser, MD, Centers for Disease Control and Prevention
- Study Director: Jesse OShea, MD, Centers for Disease Control and Prevention
- Study Director: Christine Hughes, PhD, Centers for Disease Control and Prevention
- Study Director: Brian Epling, MD, National Institutes of Health (NIH)
- Study Director: Katy Saliba, PhD, National Institutes of Health (NIH)
- Study Director: Jason Zucker, MD, Columbia University
- Study Director: Sarah Reagan Steiner, MD, Centers for Disease Control and Prevention
- Study Director: Sarah Park, MD, Karius Laboratories
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 7445