Hillsborough Township

Researchers are evaluating new treatment options for people living with HIV-1 Human Immunodeficiency Virus Type 1 who have not been treated before. The current standard treatment, antiretroviral therapy ART, involves taking multiple medicines daily and may cause other health problems. This study aims to compare a new study ART combining two medicines, islatravir and ulonivirine, taken once a week, against the standard daily ART to see if it works as well and is safe and tolerable. Participants will receive one of several treatments for 96 weeks the study ART with islatravir and ulonivirine taken once weekly, the standard ART with bictegraviremtricitabinetenofovir alafenamide BICFTCTAF taken once daily, or combinations involving placebos matching these treatments. The study includes two phases Phase 2 which is open-label, and Phase 3 which is double-blind and randomized. During the study, participants will have regular assessments including measuring the amount of HIV-1 RNA in their blood and monitoring for adverse events and medication tolerance. Researchers will evaluate how well the treatments control the virus and affect immune cells over 24, 48, and 96 weeks. Safety monitoring will continue for about 102 weeks. The total study duration for participants is up to 96 weeks of treatment plus follow-up.

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.

This research aims to evaluate a behavioral intervention called Behavioral Exposure for Interoceptive Tolerance BE-FIT designed to reduce exercise anxiety in patients undergoing cardiac rehabilitation. The study is a Stage II randomized-controlled trial involving individuals aged 40 and older who have elevated exercise anxiety and are enrolled in a cardiac rehabilitation program. The goal is to determine whether BE-FIT improves exercise adherence and to understand the mechanisms behind any changes in physical activity behavior. Participants will be randomly assigned to one of two groups the BE-FIT intervention group or a health education control HEC group. BE-FIT includes six 45-minute individual sessions over three weeks, focusing on exposure to feared bodily sensations and exercise, preventing safety behaviors around exercise, and using a wrist-worn activity monitor Fitbit for feedback and goal setting. The HEC group receives time-matched educational sessions on healthy aging topics and also uses the Fitbit for monitoring physical activity but without set activity goals. Over 24 weeks, participants will engage in six sessions delivered twice weekly alongside their cardiac rehabilitation program. Data collection includes five assessments at baseline, end of treatment, and follow-ups at weeks 12, 18, and 24. Researchers will measure overall exercise minutes, attendance at cardiac rehabilitation, and daily steps. The study involves monitoring through questionnaires, Fitbit data, and clinical supervision to assess changes in exercise anxiety and adherence.

The trial follows adults aged 20 to 70 with chronic hepatitis B CHB who previously received the investigational drug imdusiran and stopped nucleostide analog NA therapy during that earlier study. It aims to evaluate how long the effects of imdusiran on hepatitis B virus HBV parameters last over time. This observational study involves no new treatments and focuses on long-term monitoring. Participants enroll after completing their prior imdusiran trial and remain off NA therapy. The study involves no interventions beyond collecting blood samples, reviewing current medications, and recording any adverse events related to study procedures or if NA therapy is restarted. There are no additional study treatments. Participants will be followed for about 2 years to complete at least 3 years of follow-up since stopping NA therapy, including time in the parent study. Researchers will assess HBV markers to measure imdusirans lasting effect. Regular blood tests and medication reviews will monitor safety and disease status during the study.