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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL

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

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 Summary:

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.

Sponsor: Centers for Disease Control and Prevention

Current Primary Outcome: Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness

Original Primary Outcome: Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centers for Disease Control and Prevention

Dates:
Date Received: September 01, 2023
Date Started: March 17, 2023
Date Completion: March 17, 2023
Last Updated: September 18, 2023
Last Verified: September 01, 2023