Berkley

Researchers are evaluating the effectiveness of switching to injectable GS-3242 plus Lenacapavir LEN compared to continuing the oral medication Biktarvy bictegraviremtricitabinetenofovir alafenamide, BFTAF in adults with well-controlled HIV-1 infection. The study has two parts Part A focuses on people in treatment Groups 1, 2, and 3 at Week 35, while Part B focuses on Groups 4 and 3 at Week 26. This phase 2 trial aims to assess the efficacy of these treatments in virologically suppressed people with HIV-1. Participants are randomized to receive either oral loading doses of GS-3242 combined with LEN tablets followed by intramuscular IM injections of GS-3242 and LEN for up to 52 weeks, at different doses depending on the group, or to continue daily oral BFTAF for up to 52 weeks. Part B participants are enrolled non-randomized to receive oral loading doses and IM injections of GS-3242 and LEN at specific doses. The study compares these treatment approaches to evaluate viral control over specified time points. During the study, participants will have their HIV-1 RNA levels monitored at Week 26, Week 35, and Week 52 using the FDA Snapshot Algorithm to measure viral suppression. Additional assessments include CD4 cell counts, drug concentration levels in blood, and monitoring for treatment-emergent adverse events. The studys total duration extends up to 52 weeks for treatment and includes safety and efficacy evaluations at multiple time points.

Researchers are evaluating the use of lenacapavir LEN, YEZTUGO as a pre-exposure prophylaxis PrEP option for preventing HIV infections in diverse 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 assess how well participants continue using LEN PrEP over time. The main focus is to measure persistence on LEN PrEP at 52 weeks. Participants may choose LEN PrEP administered either by subcutaneous injection or orally, or select other available PrEP options such as oral tablets emtricitabinetenofovir disoproxil fumarate FTDF, emtricitabinetenofovir alafenamide FTAF, or intramuscular cabotegravir CAB, or decide not to use PrEP. The study observes these choices and follows participants over time to track how PrEP is used in real-life settings. During the study, participants will be observed at various time points up to 104 weeks to evaluate PrEP uptake, persistence, coverage, interruptions, switching between PrEP methods, and timing of LEN injections. Measurements include the proportion of days protected by PrEP and duration of use. The research team will collect data on participants choices and use of PrEP to better understand real-world PrEP use and adherence.

Researchers are evaluating how well a long-acting injectable combination treatment of lenacapavir, teropavimab, and zinlirvimab works compared to continuing daily oral HIV treatment in adults with HIV-1 who already have their virus well controlled. The study focuses on virologically suppressed people with HIV-1 and aims to measure how many participants maintain viral suppression after one year of treatment. Participants in one group will receive an initial dose of oral and injectable lenacapavir along with intravenous infusions of teropavimab and zinlirvimab on Day 1, followed by self-administered oral lenacapavir on Day 2. Every 26 weeks, they will receive additional injections and infusions up to Week 92, with an option to continue in an extension phase. The other group will continue their stable oral antiretroviral therapy as prescribed, also with an option to switch to the injectable combination after Week 92. Throughout the study, participants will be monitored for viral load levels at Weeks 52 and 92 using FDA-approved methods, changes in CD4 T-cell counts, and the presence of antibodies against study drugs. Safety will be assessed by tracking adverse events and treatment discontinuations. Drug levels will also be measured at several timepoints. The study may last until March 2033, including the extension phase for those who continue treatment.

This clinical trial investigates the effectiveness of two different long-acting injectable HIV treatments in adults with well-controlled HIV-1 on daily oral therapy. The study compares a regimen of lenacapavir LEN, teropavimab TAB, and zinlirvimab ZAB given twice a year to cabotegravir CAB and rilpivirine RPV injections given every 8 weeks. The main goal is to evaluate how well these treatments keep the virus suppressed after one year of use. Participants are randomly assigned to one of two treatment groups. One group receives oral LEN and subcutaneous LEN, along with intravenous infusions of TAB and ZAB initially and then every 26 weeks up to 92 weeks. The other group stops their current oral therapy and starts intramuscular injections of CAB and RPV on Day 1, Week 4, and every 8 weeks thereafter for up to 92 weeks. After Week 92, eligible participants may continue LEN, TAB, and ZAB in an extension phase until completion or discontinuation. During the study, participants undergo regular monitoring including HIV-1 RNA measurements to track viral load, CD4 T-cell counts, and assessments for treatment-related adverse events. Researchers will measure the proportion of participants with HIV-1 RNA levels of 50 copiesmL or higher at Week 52 as the primary outcome. Safety and drug concentration levels are also evaluated throughout the study, which may last up to several years including the extension phase.