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

Centers for Disease Control and Prevention (CDC)

Status

Enrolling

Conditions

AIDS

Monkeypox

HIV Infections

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT06045923

7445 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.