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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

Tracking Information
First Submitted Date September 1, 2023
First Posted Date September 21, 2023
Last Update Posted Date September 21, 2023
Actual Study Start Date March 17, 2023
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2023)
  • 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
  • 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
  • Immune response [ Time Frame: While hospitalized, for up to 12 months ]
    Cytokine and chemokine profile over the course of illness
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 18, 2023)
  • Clinical outcome [ Time Frame: Up to 12 months ]
    Duration of illness from mpox
  • Clinical outcome [ Time Frame: Up to 12 months ]
    Duration of hospitalization with mpox
  • Clinical outcome [ Time Frame: Up to 12 months ]
    Duration of critical illness due to mpox
  • Clinical outcome [ Time Frame: Up to 12 months ]
    Mpox lesion burden
  • Clinical outcome [ Time Frame: Up to 12 months ]
    Mortality
  • Clinical outcome [ Time Frame: Up to 12 months ]
    Characterization of co-infections
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
Official Title Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Monkeypox
  • HIV Infections
  • AIDS
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2023)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2024
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Faisal Minhaj, Pharm.D. 678-642-1093 poxvirus@cdc.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT06045923
Other Study ID Numbers 7445
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Centers for Disease Control and Prevention
Original Responsible Party Same as current
Current Study Sponsor Centers for Disease Control and Prevention
Original Study Sponsor Same as current
Collaborators Not Provided
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
PRS Account Centers for Disease Control and Prevention
Verification Date September 2023