Feasibility and Successful Enrollment in a Proof-of-Concept HIV Prevention Trial of VRC01, a Broadly Neutralizing HIV-1 Monoclonal Antibody

作者：Srilatha Edupuganti, Nyaradzo Mavis Mgodi, Shelly Karuna, P. Andrew, Erika Rudnicki, Nidhi K. Kochar, Allan C. deCamp, Robert De La Grecca, Maija Anderson, Carissa Karg, India Tindale, Elizabeth R. Greene, Gail B. Broder, Jonathan Paul Lucas, John Hural, Jorge A. Gallardo-Cartagena, Pedro Gonzáles, Ian Frank, Magdalena E. Sobieszczyk, Margarita M. Gomez Lorenzo, David Burns, Peter L. Anderson, Maurine D. Miner, Julie E. Ledgerwood, John R. Mascola, Peter B. Gilbert, Myron S. Cohen, Lawrence Corey, the HVTN 704/HPTN 085 study group · 发表于：JAIDS Journal of Acquired Immune Deficiency Syndromes · 年份：2021 · DOI：10.1097/qai.0000000000002639 · 被引用次数：28 · 研究领域：HIV Research and Treatment、HIV/AIDS Research and Interventions、Ethics in Clinical Research

BACKGROUND: The Antibody-Mediated Prevention trials (HVTN 704/HPTN 085 and HVTN 703/HPTN 081) are the first efficacy trials to evaluate whether VRC01, a broadly neutralizing monoclonal antibody targeting the CD4-binding site of the HIV envelope protein, prevents sexual transmission of HIV-1. HVTN 704/HPTN 085 enrolled 2701 cisgender men and transgender (TG) individuals who have sex with men at 26 sites in Brazil, Peru, Switzerland, and the United States. METHODS: Participants were recruited and retained through early, extensive community engagement. Eligible participants were randomized 1:1:1 to 10 mg/kg or 30 mg/kg of VRC01 or saline placebo. Visits occurred monthly, with intravenous (IV) infusions every 8 weeks over 2 years, for a total of 10 infusions. Participants were followed for 104 weeks after first infusion. RESULTS: The median HVTN 704/HPTN 085 participant age was 28 years; 99% were assigned male sex; 90% identified as cisgender men, 5% as TG women and the remaining as other genders. Thirty-two percent were White, 15% Black, and 57% Hispanic/Latinx. Twenty-eight percent had a sexually transmitted infection at enrollment. More than 23,000 infusions were administered with no serious IV administration complications. Overall, retention and adherence to the study schedule exceeded 90%, and the dropout rate was below 10% annually (7.3 per 100 person-years) through week 80, the last visit for the primary end point. CONCLUSIONS: HVTN 704/HPTN 085 exceeded accrual and retent...