NCT06045923

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Monkeypox
• HIV Infections
• AIDS

Timeline

• Start date: 2023-03-17
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2023-09-21
• Last updated: 2025-03-20

Locations

1 site across 1 country: United States