NCT06045923

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 1, 2023

Last Update Submit

April 29, 2026

Conditions

MonkeypoxHIV InfectionsAIDS

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (7)

  • Clinical outcome

    Up to 12 months

  • Clinical outcome

    Up to 12 months

  • Clinical outcome

    Up to 12 months

  • Clinical outcome

    Up to 12 months

  • Clinical outcome

    Up to 12 months

  • +2 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are hospitalized in the United States with probable/confirmed mpox and HIV with CD4 count \< 200 cells/uL.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Related Links

MeSH Terms

Conditions

Mpox, MonkeypoxHIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsPrimate DiseasesAnimal DiseasesRodent DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • 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

  • Sarah Reagan Steiner, MD

    Centers for Disease Control and Prevention

    STUDY DIRECTOR

  • Sarah Park, MD

    Karius Laboratories

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 21, 2023

Study Start

March 17, 2023

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

US(1)