A phase 3 clinical trial evaluating the antiviral tecovirimat, also known as Tpoxx, is now enrolling adults and children with monkeypox infection in the United States. Study investigators aim to enroll more than 500 people from clinical research sites nationwide. Interested volunteers can visit the ACTG website (clinical trial A5418) for more information. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The NIAID-funded AIDS Clinical Trials Group (ACTG) is leading the study, which may later expand to international sites. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at NIH is supporting several sites, including through the International Maternal Paediatric Adolescent AIDS Clinical Trials Network (IMPAACT).
Tecovirimat, manufactured by the pharmaceutical company SIGA Technologies, Inc., New York City, is approved by the US Food and Drug Administration for the treatment of smallpox. The drug prevents the virus from spreading in the body by preventing virus particles from exiting human cells by targeting a protein found on both the variola virus, which causes smallpox, and the monkeypox virus. Clinicians currently can access tecovirimat for US patients with monkeypox through an expanded access or
