Safety, tolerability, and acceptability of long-acting injectable cabotegravir for HIV prevention in cisgender female adolescents (HPTN 084-01): a single-arm, open-label, phase 2b trial

作者：Lynda Stranix‐Chibanda, E.L. Hamilton, Julie Ngo, Yuqing Jiao, Brett Hanscom, Rahul Paul Choudhury, Yaw Agyei, Estelle Piwowar-Manning, Mark A. Marzinke, Sinéad Delany‐Moretlwe, Nyaradzo Mgodi, Bekezela Siziba, Ishana Naidoo, Brenda Gati Mirembe, Betty Kamira, Cynthia McCoig, Adeola Adeyeye, Hans Spiegel, Sybil Hosek · 发表于：The Lancet HIV · 年份：2025 · DOI：10.1016/s2352-3018(24)00310-2 · 被引用次数：8 · 研究领域：HIV/AIDS Research and Interventions、HIV, Drug Use, Sexual Risk、HIV-related health complications and treatments

BACKGROUND: Long-acting formulations of HIV pre-exposure prophylaxis (PrEP) appear particularly well suited to adolescents. We aimed to establish the safety, tolerability, and acceptability of long-acting injectable cabotegravir as PrEP in cisgender adolescent girls. METHODS: HPTN 084-01 is a single-arm, open-label, phase 2b trial conducted at three clinical research sites in South Africa, Uganda, and Zimbabwe. Girls were recruited via community study-outreach teams, reproductive health clinics, and peer referral. Sexually active adolescent girls (younger than 18 years) willing to use long-acting contraception, weighing at least 35 kg, and able to participate with parental or guardian consent (unless an emancipated minor) were eligible. After an oral lead-in, if no adverse events occurred, participants received a 3 mL intramuscular gluteal injection (long-acting injectable cabotegravir 600 mg) at weeks 5, 9, 17, 25, and 33. The product was discontinued for grade 3 or higher toxic effects or pregnancy. The primary outcomes were safety, tolerability, and acceptability. Safety (ie, proportions of grade 2 or higher clinical and laboratory events) was assessed at weeks 6, 10, 18, 26, and 34 in all enrolled participants. Injection tolerability (ie, proportions of premature discontinuation due to intolerability, frequency of injections, or burden of study procedures) and product acceptability (ie, proportions of scheduled injections completed and participants preferring long-acting ...