Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
NCT ID: NCT06045923
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-03-17
2026-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Outpatient
15 outpatients will be recruited from a single pre-determined clinical site (Columbia University)
No interventions assigned to this group
Inpatient
Up to 85 hospitalized patients will be recruited from other participating clinical sites
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Responsible Party
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Principal Investigators
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Agam Rao, MD
Role: PRINCIPAL_INVESTIGATOR
Centers for Disease Control and Prevention
Irini Sereti, MD
Role: STUDY_DIRECTOR
National Institutes of Health (NIH)
Faisal Minhaj, Pharm.D.
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention
Shama Cash-Goldwasser, MD
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention
Jesse OShea, MD
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention
Christine Hughes, PhD
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention
Brian Epling, MD
Role: STUDY_DIRECTOR
National Institutes of Health (NIH)
Katy Saliba, PhD
Role: STUDY_DIRECTOR
National Institutes of Health (NIH)
Jason Zucker, MD
Role: STUDY_DIRECTOR
Columbia University
Sarah Reagan Steiner, MD
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention
Sarah Park, MD
Role: STUDY_DIRECTOR
Karius Laboratories
Locations
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Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Countries
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Central Contacts
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Related Links
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Clinician Fact Sheet
VIRISMAP PowerPoint Presentation
Other Identifiers
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7445
Identifier Type: -
Identifier Source: org_study_id
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