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

Recruiting

• Conditions: Monkeypox; AIDS; HIV Infections

• Registration Number: NCT06045923
• Lead Sponsor: Centers for Disease Control and Prevention

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 Timeline

• Study Start: 2023-03-17
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Immune response	While hospitalized, for up to 12 months	Cytokine and chemokine profile 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

Secondary Outcome Measures

Name	Time	Method
Clinical outcome	Up to 12 months	Characterization of co-infections
Monkeypox virus resistance	While hospitalized, for up to 12 months	Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness

Trial Locations

Locations (1)

Centers for Disease Control and Prevention; 🇺🇸 Atlanta, Georgia, United States