In The News: How Researchers Were Able to Enroll Adolescents in Landmark HIV Trial

Healio reports a landmark trial of lenacapavir successfully and ethically enrolled adolescents into its study on the HIV prevention shot.  Lenacapavir is a long-acting antiretroviral injection that is given twice a year. It is already approved in the U.S. for treatment of resistant HIV infections. The FDA is scheduled to decide in June on its use as long-acting PrEP.

This phase 3 study, PURPOSE 1, demonstrated lenacapavir was safe, well-tolerated and 100% effective at preventing HIV in adolescent girls and young women in South Africa and Uganda. It was the first large-scale phase 3 HIV prevention study to include 16- and 17-year-old participants from the very beginning of the study. That decision to intentionally enroll adolescents, who are typically excluded from HIV prevention studies, could mean the age group will not have to wait for access, should the FDA approve.

Researchers engaged adolescent medicine experts and parental consent at trial sites to successfully include adolescents in the study. The researchers also used an innovation in the consent process by having a site community advisory board. The advisory board-led effort issued waivers for parental consent that adolescents could use to grant consent for themselves. Other areas considered pregnant adolescents as emancipated and able to provide consent.

The study included 124 participants in the 16- and 17-year-old groups. Of those, 56 were assigned to receive lenacapavir. Researchers noted plasma concentrations between adults and adolescents were similar. There were also similarities between the groups in reports of adverse events, including injection site reaction, headache, and UTI. The follow up trial, PURPOSE 2, will also include adolescents in the testing.

PIDS member and chair of the PIDS Pediatric HIV Interest Group, Rosemary Olivero, commented, “We in the Pediatric HIV community are delighted to see that the PURPOSE 1 and 2 trials were able to break through the longstanding tradition of excluding those less than 18 years of age in impactful clinical trials such as these. Infants, children and adolescents are often the last groups to be included in clinical trials, which significantly delays the approval, licensing and use of potentially beneficial preventative and therapeutic medications in these groups. We look forward to expanding upon the progress that PROMISE 1 and 2 have made in including pediatric subjects in clinical trials.”