Examining mpox in people with advanced HIV
Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
This study is trying to understand how the mpox virus behaves in people with advanced HIV and how antiviral treatments affect both infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centers for Disease Control and Prevention Federal |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06045923 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between the immune response and the spread of the mpox virus in individuals with advanced HIV. It will assess how the virus persists and replicates in various body sites, including blood and mucosal areas, during the course of mpox illness. Additionally, the study will explore the emergence of antiviral drug resistance and the effects of antiviral treatments on both mpox and HIV. The findings are expected to enhance understanding of mpox pathogenesis in severely immunocompromised patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with HIV and a CD4 count below 200 cells/uL who are hospitalized with symptomatic mpox.
Not a fit: Patients who do not have advanced HIV or are not experiencing symptoms of mpox may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment and prevention strategies for severe mpox in patients with advanced HIV.
How similar studies have performed: While there may be studies on mpox and HIV separately, this specific approach focusing on the intersection of severe mpox and advanced HIV is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlanta, Georgia
- Centers for Disease Control and Prevention — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Agam Rao, MD — Centers for Disease Control and Prevention
- Study coordinator: Faisal Minhaj, Pharm.D.
- Email: poxvirus@cdc.gov
- Phone: 678-642-1093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.