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We performed a single-center, randomized, double-blind, dose-escalation, placebo-controlled trial of a single administration of the HIV-1 V3-glycan-specific antibody PGT121 at 3, 10 and 30\u2009mg\u2009kg\n                    <jats:sup>\u20131<\/jats:sup>\n                    in HIV-uninfected adults and HIV-infected adults on antiretroviral therapy (ART), as well as a multicenter, open-label trial of one infusion of PGT121 at 30\u2009mg\u2009kg\n                    <jats:sup>\u20131<\/jats:sup>\n                    in viremic HIV-infected adults not on ART (no. NCT02960581). The primary endpoints were safety and tolerability, pharmacokinetics (PK) and antiviral activity in viremic HIV-infected adults not on ART. The secondary endpoints were changes in anti-PGT121 antibody titers and CD4\n                    <jats:sup>+<\/jats:sup>\n                    \u2009T-cell count, and development of HIV-1 sequence variations associated with PGT121 resistance. Among 48\u2009participants enrolled, no treatment-related serious adverse events, potential immune-mediated diseases or Grade\u20093 or higher adverse events were reported. The most common reactions among PGT121 recipients were intravenous\/injection site tenderness, pain and headache. Absolute and relative CD4\n                    <jats:sup>+<\/jats:sup>\n                    \u2009T-cell counts did not change following PGT121 infusion in HIV-infected participants. Neutralizing anti-drug antibodies were not elicited. PGT121 reduced plasma HIV RNA levels by a median of 1.77\u2009log in viremic participants, with a viral load nadir at a median of 8.5\u2009days. Two individuals with low baseline viral loads experienced ART-free viral suppression for \u2265168\u2009days following antibody infusion, and rebound viruses in these individuals demonstrated full or partial PGT121 sensitivity. The trial met the prespecified endpoints. These data suggest that further investigation of the potential of antibody-based therapeutic strategies for long-term suppression of HIV is warranted, including in individuals off ART and with low viral load.\n                  <\/jats:p>","DOI":"10.1038\/s41591-021-01509-0","type":"journal-article","created":{"date-parts":[[2021,10,7]],"date-time":"2021-10-07T12:04:41Z","timestamp":1633608281000},"page":"1718-1724","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":106,"title":["Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial"],"prefix":"10.1038","volume":"27","author":[{"given":"Kathryn E.","family":"Stephenson","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Julg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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