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NCT06045923 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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