Clinical trial NCT06045923: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monkeypox
HIV Infections
AIDS
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Monkeypox viral persistence
timeFrame: While hospitalized, for up to 12 months
measure: Monkeypox viral viability
timeFrame: While hospitalized, for up to 12 months
measure: Immune response
timeFrame: While hospitalized, for up to 12 months
Secondary outcomes:
measure: Clinical outcome
timeFrame: Up to 12 months
measure: Clinical outcome
timeFrame: Up to 12 months
measure: Clinical outcome
timeFrame: Up to 12 months
measure: Clinical outcome
timeFrame: Up to 12 months
measure: Clinical outcome
timeFrame: Up to 12 months
measure: Clinical outcome
timeFrame: Up to 12 months
measure: Monkeypox virus resistance
timeFrame: While hospitalized, for up to 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Agam Rao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institutes of Health (NIH)
name: Irini Sereti, MD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: Faisal Minhaj, Pharm.D.
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: Shama Cash-Goldwasser, MD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: Jesse OShea, MD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: Christine Hughes, PhD
role: STUDY_DIRECTOR
affiliation: National Institutes of Health (NIH)
name: Brian Epling, MD
role: STUDY_DIRECTOR
affiliation: National Institutes of Health (NIH)
name: Katy Saliba, PhD
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Jason Zucker, MD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: Sarah Reagan Steiner, MD
role: STUDY_DIRECTOR
affiliation: Karius Laboratories
name: Sarah Park, MD
role: STUDY_DIRECTOR
References: