AIDS, HIV Infections, Monkeypox
Conditions
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.
Interventions
None listed
Sponsors
Centers for Disease Control and Prevention
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | Up to 12 months | Duration of illness from mpox |
| Monkeypox virus resistance | While hospitalized, for up to 12 months | Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAgam Rao, MD
Centers for Disease Control and Prevention
STUDY_DIRECTORIrini Sereti, MD
National Institutes of Health (NIH)
STUDY_DIRECTORFaisal Minhaj, Pharm.D.
Centers for Disease Control and Prevention
STUDY_DIRECTORShama Cash-Goldwasser, MD
Centers for Disease Control and Prevention
STUDY_DIRECTORJesse OShea, MD
Centers for Disease Control and Prevention
STUDY_DIRECTORChristine Hughes, PhD
Centers for Disease Control and Prevention
STUDY_DIRECTORBrian Epling, MD
National Institutes of Health (NIH)
STUDY_DIRECTORKaty Saliba, PhD
National Institutes of Health (NIH)
STUDY_DIRECTORJason Zucker, MD
Columbia University
STUDY_DIRECTORSarah Reagan Steiner, MD
Centers for Disease Control and Prevention
STUDY_DIRECTORSarah Park, MD
Karius Laboratories
Outcome results
None listed