Fort Pierce

Researchers are studying a new treatment for HIV-1 infection that combines two medicines, islatravir and ulonivirine, taken once weekly. The goal is to see if this new study treatment works as well as the standard antiretroviral therapy (ART), which usually involves taking up to three medicines once or twice daily. This research also aims to learn about the safety and tolerability of the study treatment compared to the standard ART. The study compares the once-weekly combination of islatravir and ulonivirine with the standard daily treatment of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Participants will take either the study drugs or the standard drugs for 96 weeks. Some participants may receive matching placebos as part of the study design. The treatment is given orally as capsules or tablets according to the assigned group. Participants will be monitored throughout the study with regular assessments, including measuring the amount of HIV-1 virus in the blood to see if it is suppressed below 50 copies/mL at weeks 24 and 48. The study will also track any side effects or adverse events and whether participants stop the treatment due to these events. Overall, the study lasts about 96 weeks, with ongoing safety and effectiveness evaluations to understand how well the treatments work and how safe they are over time.

This clinical study is testing a new medication, VH4524184, to see if it can effectively treat HIV-1 in adults who have never received treatment for their infection. The study is comparing two different doses of VH4524184, each taken with the medications emtricitabine and tenofovir alafenamide (FTC/TAF), to a standard HIV treatment called dolutegravir and lamivudine (DTG/3TC). The purpose of the study is to provide data on the long-term antiviral activity of the VH4524184 and provide information regarding dosing formulation for further evaluations.

Researchers are evaluating the combination of two monoclonal antibodies, TMB-365 and TMB-380, as maintenance therapy for people living with HIV-1 who have their virus suppressed with combination antiretroviral therapy (cART). These antibodies work by interfering with HIV entry into cells. The study is a Phase 2b trial comparing this antibody combination to the standard daily oral cART in maintaining viral suppression over 48 weeks. Participants are assigned to receive either the TMB-365 and TMB-380 antibodies through intravenous infusions every 8 weeks or to continue with their daily oral cART regimen. The antibodies target different aspects of the virus: TMB-365 blocks the CD4 receptor, and TMB-380 neutralizes the virus itself. The treatment period lasts 48 weeks, during which participants follow their assigned therapy schedule. Throughout the study, participants will visit the clinic regularly for check-ups and tests to monitor their health and viral levels. Researchers will measure the antiviral activity of the antibody combination compared to daily oral cART at week 48. The study also involves safety monitoring, laboratory assessments including blood counts and liver/kidney function, and adherence checks. Participants are expected to comply with the study procedures and follow-up visits for the full duration of 48 weeks.

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.