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

HIV Infections Clinical Trial

— VIRISMAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045923
• Other study ID #: 7445
• Status: Recruiting
• Start date: March 17, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2023
• Source: Centers for Disease Control and Prevention
• Contact: Faisal Minhaj, Pharm.D.
• Phone: 678-642-1093
• Email: poxvirus[@]cdc.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• HIV Infections
• Monkeypox

Locations

Country	Name	City	State
United States	Centers for Disease Control and Prevention	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monkeypox viral persistence	Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness	While hospitalized, for up to 12 months
Primary	Monkeypox viral viability	Monkeypox virus viability in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness	While hospitalized, for up to 12 months
Primary	Immune response	Cytokine and chemokine profile over the course of illness	While hospitalized, for up to 12 months
Secondary	Clinical outcome	Duration of illness from mpox	Up to 12 months
Secondary	Clinical outcome	Duration of hospitalization with mpox	Up to 12 months
Secondary	Clinical outcome	Duration of critical illness due to mpox	Up to 12 months
Secondary	Clinical outcome	Mpox lesion burden	Up to 12 months
Secondary	Clinical outcome	Mortality	Up to 12 months
Secondary	Clinical outcome	Characterization of co-infections	Up to 12 months
Secondary	Monkeypox virus resistance	Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness	While hospitalized, for up to 12 months

External Links

•   Clinician Fact Sheet
•   VIRISMAP PowerPoint Presentation