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

Phase

N/A

Condition

Hiv Infections

Hiv

Treatment

N/A

Clinical Study ID

NCT06045923

7445

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 otherfactor that might affect their ability to participate in the evaluation.

Study Design

March 17, 2023

October 01, 2026

Study 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.

Connect with a study center

Centers for Disease Control and Prevention
Atlanta, Georgia 30333
United States
Active - Recruiting

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