An observational study in Monkeypox, HIV Infections and AIDS, sponsored by Centers for Disease Control and Prevention. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Centers for Disease Control and Prevention · Observational
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:
72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.
This study's enrollment of 100 is below the median of 224 across 34 observational studies indexed under Mpox, Monkeypox.
Browse Mpox, Monkeypox studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are hospitalized in the United States with probable/confirmed mpox and HIV with CD4 count \< 200 cells/uL.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 outpatients will be recruited from a single pre-determined clinical site (Columbia University)
Up to 85 hospitalized patients will be recruited from other participating clinical sites
Monkeypox viral persistence
Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness
Time frame: 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
Time frame: While hospitalized, for up to 12 months
Immune response
Cytokine and chemokine profile over the course of illness
Time frame: While hospitalized, for up to 12 months
Clinical outcome
Duration of illness from mpox
Time frame: Up to 12 months
Clinical outcome
Duration of hospitalization with mpox
Time frame: Up to 12 months
Clinical outcome
Duration of critical illness due to mpox
Time frame: Up to 12 months
Clinical outcome
Mpox lesion burden
Time frame: Up to 12 months
Clinical outcome
Mortality
Time frame: Up to 12 months
Clinical outcome
Characterization of co-infections
Time frame: Up to 12 months
Monkeypox virus resistance
Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness
Time frame: While hospitalized, for up to 12 months
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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