Hillsborough Township

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 research focuses on people with chronic hepatitis B (CHB) who previously took part in a clinical trial for a treatment called imdusiran. The study aims to follow these individuals long-term after they have stopped taking nucleos(t)ide analogue (NA) therapy, which they discontinued during the earlier trial. Participants must have completed the prior trial and remain off NA therapy, with less than three years of follow-up since stopping NA treatment. The study will help understand how long the effects of imdusiran on hepatitis B virus (HBV) parameters last. The study does not involve any new treatments or interventions. Instead, it is a non-interventional, rollover follow-up study where participants will be observed for about two years. During this time, researchers will collect blood samples, review current medications, and record any side effects related to study procedures or if NA therapy is restarted. This follow-up period will complete at least three years of monitoring after NA therapy has stopped, including the time from the previous trial. Participants will be asked to attend scheduled visits for blood sample collection and to provide updates on their health and medication use. The study will monitor the durability of imdusiran's effects on HBV over up to 96 weeks. Safety is tracked by reporting any adverse events that may occur during the study. Overall, the entire study participation will last approximately two years, following the initial trial involvement.