A single infusion of an experimental anti-HIV antibody called 3BNC117 resulted in significantly decreased HIV levels that persisted for as long as 28 days in HIV-infected individuals, according to Phase 1 clinical trial findings published online today in Nature. Major funding for the research was provided by the Bill & Melinda Gates Foundation, The Rockefeller University, and supported in part by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH. The research was led by long-time NIAID grantee Michel C. Nussenzweig, M.D., Ph.D., of the Howard Hughes Medical Institute at The Rockefeller University in New York City.
Before its first-in-human testing, the 3BNC117 antibody had neutralized many diverse HIV strains in laboratory tests and had protected humanized mice and macaques from HIV and its simian equivalent. To determine if the investigational product would be safe and potentially effective in people, the research team conducted a small clinical trial among 29 volunteers, 17 HIV-infected and 12 uninfected individuals. Study participants received a single intravenous dose of 3BNC117 of 1, 3, 10 or 30 milligrams. The investigational product was well-tolerated by all participants. Among HIV-infected participants, 3BNC117 had the greatest effect on the eight participants who received the highest dose, resulting in significant and rapid decreases in viral load. HIV resistance to 3BNC117 was variable, but some individuals remained sensitive to the antibody for 28 days.
Based on the findings, the authors conclude that 3BNC117 is safe in people and can have a substantial effect on controlling HIV levels and should, therefore, be explored further for use in HIV prevention and treatment. Additionally, in the future the investigational antibody may be used to help eradicate HIV from latent reservoirs in an infected person's body, according to the authors.
M Caskey et al. Viraemia suppressed in HIV-1-infected humans by broadly neutralizing antibody 3BNC117. Nature DOI: 10.1038/nature14411 (2015).
NIAID Director Anthony S. Fauci, M.D., is available for comment.