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

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ClinicalTrials.gov Identifier: NCT06045923
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Study Description
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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
Monkeypox HIV Infections AIDS

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:

  • 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
Actual Study Start Date : March 17, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Monkeypox viral persistence [ Time Frame: 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

  2. Monkeypox viral viability [ Time Frame: 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

  3. Immune response [ Time Frame: While hospitalized, for up to 12 months ]
    Cytokine and chemokine profile over the course of illness


Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: Up to 12 months ]
    Duration of illness from mpox

  2. Clinical outcome [ Time Frame: Up to 12 months ]
    Duration of hospitalization with mpox

  3. Clinical outcome [ Time Frame: Up to 12 months ]
    Duration of critical illness due to mpox

  4. Clinical outcome [ Time Frame: Up to 12 months ]
    Mpox lesion burden

  5. Clinical outcome [ Time Frame: Up to 12 months ]
    Mortality

  6. Clinical outcome [ Time Frame: Up to 12 months ]
    Characterization of co-infections

  7. Monkeypox virus resistance [ Time Frame: While hospitalized, for up to 12 months ]
    Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are hospitalized in the United States with probable/confirmed mpox and HIV with CD4 count < 200 cells/uL.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045923


Contacts
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Contact: Faisal Minhaj, Pharm.D. 678-642-1093 poxvirus@cdc.gov

Locations
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United States, Georgia
Centers for Disease Control and Prevention Recruiting
Atlanta, Georgia, United States, 30333
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT06045923    
Other Study ID Numbers: 7445
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mpox (monkeypox)
Infections
Virus Diseases
Poxviridae Infections
DNA Virus Infections