Berkley

Researchers are evaluating the effectiveness, safety, and durability of a long-acting injectable antiretroviral therapy (ART) combining Cabotegravir (CAB LA) and Rilpivirine (RPV LA) in people living with HIV who have detectable virus levels despite taking oral ART. This Phase 3b, open-label, randomized study compares this injectable treatment to standard oral ART. The study also seeks to gather patient feedback on their experience with the injectable regimen. Participants in the study will receive monthly intramuscular injections of CAB LA + RPV LA for the first two doses, followed by injections every two months. The control group will continue their oral ART as prescribed by their healthcare provider. The study includes a standard-of-care control arm and is conducted at multiple centers to assess the superiority of the injectable treatment. During the study, participants will be monitored for viral suppression at 6 months as the primary outcome. Researchers will track safety, tolerability, and participant adherence through clinical assessments and patient reports. The total duration of the study and additional monitoring details are based on visits scheduled through Month 6, focusing on virologic response and treatment experience.

Researchers are studying how lenacapavir (LEN, YEZTUGO®) is used for HIV prevention as pre-exposure prophylaxis (PrEP) in real-world clinical settings across the United States. This observational study aims to understand how LEN PrEP is started, used, and stopped in routine practice and to evaluate how long people continue using LEN PrEP over one year. The main goal is to measure the proportion of participants who remain on LEN PrEP at 52 weeks. The study includes various PrEP options such as lenacapavir given as a subcutaneous injection, lenacapavir tablets taken orally, oral tablets of emtricitabine/tenofovir disoproxil fumarate (F/TDF) or emtricitabine/tenofovir alafenamide (F/TAF), and cabotegravir administered by intramuscular injection. Participants can choose LEN PrEP or other available PrEP methods after counseling about their benefits and risks. The study observes participants who are new to PrEP as well as those currently or previously using oral or injectable PrEP. Participants will be involved in routine clinical care and followed to track their use and persistence on LEN PrEP over a year. Researchers will collect information on how often participants stay on LEN PrEP at week 52, using standard testing to confirm HIV-negative status at screening. The study captures real-life data on PrEP use in diverse clinical sites to help understand the patterns and outcomes of LEN PrEP for HIV prevention.

Researchers are evaluating the safety, tolerability, and how the drug lenacapavir (LEN) is processed in the body when given as a once-yearly injection for HIV pre-exposure prophylaxis (PrEP). This Phase 3 study focuses on people who have indications for PrEP, aiming to better understand LEN's effects and how it is absorbed, modified, distributed, and removed from the body. The study involves administering lenacapavir either as an intramuscular injection once every 12 months or as oral tablets. The primary focus is on the intramuscular injection given yearly to prevent HIV infection in at-risk individuals. No comparator group or placebo is mentioned, indicating this is a single-arm trial assessing the study drug's long-term use. Participants will be monitored for drug levels in the blood at 52 weeks, and safety assessments will include tracking any treatment-emergent adverse events, laboratory abnormalities, or discontinuations due to side effects for up to about three years after the first dose. This comprehensive follow-up helps assess the drug's long-term tolerability and safety profile in people receiving LEN for HIV prevention.