Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Insufficient participant enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient | 15 outpatients will be recruited from a single pre-determined clinical site (Columbia University) | ||
| Inpatient | Up to 85 hospitalized patients will be recruited from other participating clinical sites |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Immune response | Cytokine and chemokine profile over the course of illness | While hospitalized, for up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome | Duration of illness from mpox | Up to 12 months |
| Clinical outcome | Duration of hospitalization with mpox | Up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who are hospitalized in the United States with probable/confirmed mpox and HIV with CD4 count < 200 cells/uL.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Agam Rao, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Irini Sereti, MD | National Institutes of Health (NIH) | Study Director |
| Faisal Minhaj, Pharm.D. | Centers for Disease Control and Prevention | Study Director |
| Shama Cash-Goldwasser, MD | Centers for Disease Control and Prevention | Study Director |
| Jesse OShea, MD | Centers for Disease Control and Prevention | Study Director |
| Christine Hughes, PhD | Centers for Disease Control and Prevention | Study Director |
| Brian Epling, MD | National Institutes of Health (NIH) | Study Director |
| Katy Saliba, PhD | National Institutes of Health (NIH) | Study Director |
| Jason Zucker, MD | Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centers for Disease Control and Prevention | Atlanta | Georgia | 30333 | United States |
Not provided
| Label | URL |
|---|---|
| VIRISMAP PowerPoint Presentation | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D045908 | Mpox, Monkeypox |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| Clinical outcome | Duration of critical illness due to mpox | Up to 12 months |
| Clinical outcome | Mpox lesion burden | Up to 12 months |
| Clinical outcome | Mortality | Up to 12 months |
| Clinical outcome | Characterization of co-infections | Up to 12 months |
| Monkeypox virus resistance | Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness | While hospitalized, for up to 12 months |
| Sarah Reagan Steiner, MD |
| Centers for Disease Control and Prevention |
| Study Director |
| Sarah Park, MD | Karius Laboratories | Study Director |
| D018419 |
| Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |