MonkeypoxVIRISMAPNCT06045923
Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
An observational study of Monkeypox and HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monkeypox, HIV Infections, AIDS
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are hospitalized in the United States with probable/confirmed mpox and HIV with CD4 count < 200 cells/uL.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
About this study
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.
Read the detailed 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.
- Conditions
- Monkeypox, HIV Infections, AIDS
- Medical subject headings
- Mpox, Monkeypox, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monkeypox viral persistence
Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness
Measured: 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
Measured: While hospitalized, for up to 12 months
Immune response
Cytokine and chemokine profile over the course of illness
Measured: While hospitalized, for up to 12 months
Secondary outcomes (7)
Clinical outcome
Duration of illness from mpox
Measured: Up to 12 months
Clinical outcome
Duration of hospitalization with mpox
Measured: Up to 12 months
Clinical outcome
Duration of critical illness due to mpox
Measured: Up to 12 months
Clinical outcome
Mpox lesion burden
Measured: Up to 12 months
Clinical outcome
Mortality
Measured: Up to 12 months
Clinical outcome
Characterization of co-infections
Measured: Up to 12 months
Monkeypox virus resistance
Assess Monkeypox virus isolates for resistance to available therapeutics over the course of illness
Measured: While hospitalized, for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Mar 2023
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Why it stopped: Insufficient participant enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Agam Rao, MD, Principal investigator, Centers for Disease Control and PreventionIrini Sereti, MD, Study director, National Institutes of Health (NIH)Faisal Minhaj, Pharm.D., Study director, Centers for Disease Control and PreventionShama Cash-Goldwasser, MD, Study director, Centers for Disease Control and PreventionJesse OShea, MD, Study director, Centers for Disease Control and PreventionChristine Hughes, PhD, Study director, Centers for Disease Control and PreventionBrian Epling, MD, Study director, National Institutes of Health (NIH)Katy Saliba, PhD, Study director, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045923
- Sponsor's protocol ID
- 7445
- Acronym
- VIRISMAP
- Status last verified
- Apr 2026
- First submitted
- 1 Sep 2023
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
- ClinicalTrials.gov ID
- NCT06045923
- Acronym / sponsor ID
- VIRISMAP / 7445
- Conditions
- Monkeypox, HIV Infections, AIDS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient participant enrollment
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are hospitalized in the United States with probable/confirmed mpox and HIV with CD4 count < 200 cells/uL.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Monkeypox viral persistence
Time frame: While hospitalized, for up to 12 months
Monkeypox virus persistence in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness
Monkeypox viral viability
Time frame: While hospitalized, for up to 12 months
Monkeypox virus viability in different sample types (including lesion, oropharyngeal, and rectal swabs; blood) over the course of illness
Immune response
Time frame: While hospitalized, for up to 12 months
Cytokine and chemokine profile over the course of illness
7 secondary outcomes
Clinical outcome
Time frame: Up to 12 months
Clinical outcome
Time frame: Up to 12 months
Clinical outcome
Time frame: Up to 12 months
Clinical outcome
Time frame: Up to 12 months
Clinical outcome
Time frame: Up to 12 months
Clinical outcome
Time frame: Up to 12 months
Monkeypox virus resistance
Time frame: While hospitalized, for up to 12 months
Results and safety
The study was stopped early (reason given: Insufficient participant enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agam Rao, MD principal investigator
Centers for Disease Control and Prevention
Irini Sereti, MD study director
National Institutes of Health (NIH)
Faisal Minhaj, Pharm.D. study director
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox and HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient participant enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monkeypox viral persistence (time frame: While hospitalized, for up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.