Bellavista

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating elritercept TAK-226, KER-050, an investigational drug, for treating anemia in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who need regular red blood cell RBC transfusions. The study is a Phase 3, randomized, double-blind, placebo-controlled trial designed to assess how well elritercept reduces the need for RBC transfusions and to evaluate its safety and tolerability over time. Participants will be randomly assigned in a 21 ratio to receive either elritercept or a matching placebo, both given as subcutaneous injections every 4 weeks. The study includes a Primary Phase lasting 24 weeks and a Secondary Phase lasting an additional 24 weeks, during which participants continue their assigned treatments. Eligible participants may also enter an Extension Phase to continue treatment until individual discontinuation or study unblinding. After treatment ends, a Safety Follow-Up Period of 8 weeks and a long-term follow-up lasting up to 5 years will monitor participants. During the study, participants will have visits approximately every 2 weeks initially, then every 4 weeks, to assess treatment effects and safety. Researchers will evaluate the percentage of participants achieving transfusion independence and monitor adverse events, laboratory values, vital signs, and heart tests. Long-term follow-up will continue through regular check-ins for up to five years or until the participant withdraws or the study ends.

Researchers are evaluating a lab-made antibody called ePGT121v1-LS designed to target a specific part of HIV. This Phase 1 clinical trial also studies this antibody alone and in combination with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. The study aims to assess the safety, side effects, proper dosing, how the body processes these antibodies, and their ability to neutralize HIV in the blood. The trial includes about 83 generally healthy adults without HIV-1, aged 18 to 55. Participants are divided into two parts. In Part A, six groups receive ePGT121v1-LS by intravenous IV infusion at various doses, either alone or combined with the other two antibodies, given at two visits 24 weeks apart over 48 weeks. In Part B, two groups receive subcutaneous SC injections either of ePGT121v1-LS alone or combined with the other antibodies, given at two visits 12 weeks apart over 24 weeks. Each dose and administration schedule is carefully studied in these groups. Throughout the study, participants attend scheduled clinic visits for up to 48 weeks depending on their group. They will be monitored for local and systemic side effects, laboratory safety tests, and the levels of antibodies in their blood. Researchers will track how the antibodies are absorbed, distributed, and cleared, along with their neutralizing activity against HIV. Safety, tolerability, and antibody interactions are key outcomes during the follow-up period.

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in bronchiectasis patients who are chronically colonized with Pseudomonas aeruginosa PsA. This Phase IIb study compares two dosage regimens of AZD0292 administered intravenously with placebo in participants aged 12 years and older. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent pulmonary exacerbations due to chronic PsA colonization, which negatively affects lung function, quality of life, and survival. Additionally, patients with cystic fibrosis bronchiectasis colonized with PsA are included as an exploratory group. Participants will receive either high-dose or low-dose AZD0292 starting on Day 1 via IV infusion, or placebo administered similarly. Subsequent doses will follow a schedule of assessments. This randomized, double-blind, placebo-controlled, parallel study aims to assess the efficacy, safety, and pharmacokinetics of AZD0292 over a variable follow-up period ranging from a minimum of 28 weeks up to 52 weeks. The trial also includes monitoring for adverse events and immune responses to the treatment. During the study, participants will undergo evaluations including lung function tests, quality of life questionnaires, and monitoring of exacerbation rates. Blood samples will be collected to measure drug concentration and antibody development. Safety assessments will continue through the treatment period and for up to 24 weeks after the last dose. The primary outcome is the annualized rate of exacerbations over the follow-up time, and secondary measures include severe exacerbation rates, time to first exacerbation, and changes in quality of life scores. Total participation spans from screening through the treatment and follow-up phases.

Researchers are evaluating the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are generally healthy. This phase 1 clinical trial aims to determine if these vaccines can initiate or boost antibody responses against HIV. The study also examines how a closely monitored planned pause in antiretroviral therapy ATI influences these immune responses. Participants will receive a series of vaccine injections one group receives DV700P-RNA at weeks 0 and 8, followed by DV701B1.1-RNA at week 16 another group receives DV700P-RNA at week 0 and DV701B1.1-RNA at week 8. Each vaccine is given by intramuscular injection. The trial uses a sequential design with no randomization or masking. During the study, participants will undergo assessments of local and systemic reactions following vaccinations, monitoring for serious and medically attended adverse events through up to 88 weeks. Immune responses will be measured by analyzing antibody levels and B-cell activity at baseline, after vaccinations, and after restarting antiretroviral therapy. The study involves multiple visits for vaccinations and monitoring, lasting approximately up to 88 weeks in total.

Researchers are evaluating the safety and immune response of a vaccine called Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env VRIPRO in adults aged 18 to 60 years who previously participated in the HVTN 706 trial and are currently without HIV and in good health. This Phase 1 clinical trial aims to better understand the vaccines effects in this specific group and is sponsored by the National Institute of Allergy and Infectious Diseases NIAID. Participants will receive three subcutaneous injections of the vaccine at weeks 0, 4, and 24. The vaccine includes the CD40.HIVRI.Env VRIPRO biological agent combined with Hiltonol Poly-ICLC as an adjuvant to enhance the immune response. The study is open-label and non-randomized, with all participants receiving the investigational vaccine. During the study, researchers will monitor local and systemic reactions for at least 14 days after each vaccination. They will also track any serious or adverse events for up to one year after the last dose. Blood samples will be collected to measure various immune responses, including specific antibody levels and T-cell activity, at multiple time points. Participants will be followed closely through clinic visits and contacted 12 months after the final vaccination to assess long-term safety and immune response.

This research aims to understand how HIV care is decentralized in Peru to improve retention in care and viral suppression among people with HIV. Decentralizing HIV services is an important strategy that has not been widely studied with experimental designs, especially in urban areas. This study will provide valuable insights for future efforts to decentralize HIV treatment both in Peru and other countries. The study uses a step-wedge design to assess how decentralized HIV services are adopted and expanded across primary health clinics PHCs in Peru over 54 months. A behavioral intervention combining NIATx Network for the Improvement of Addiction Treatment with Project ECHO tele-education connects secondary health centers SHCs and PHCs in a hub and spoke model. The intervention is rolled out in phases including control, active NIATxECHO training, and maintenance periods to support guideline-based decentralization. Participants include clinicians and leaders working at PHCs and SHCs involved in HIV care. Researchers will evaluate the percentage of people with HIV treated in PHCs, retention in care, and viral suppression rates over the study period. The study also monitors how well clinics adopt the intervention and follow decentralization guidelines. The total observation lasts up to 54 months, with assessments to understand barriers and facilitators to decentralized HIV care.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Central nervous system CNS tumors are the most common solid cancers in children, with embryonal tumors making up about 20-25% of these cases. This international registry focuses on rare embryonal tumors of the CNS, such as ETMR, FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, CNS tumor with BCOR internal tandem duplication, and others. These tumors are very rare, difficult to diagnose, and lack standard treatment guidelines due to limited data. The registry aims to collect detailed information to better understand these tumors characteristics, treatments, and outcomes. The study collects data retrospectively and prospectively from children and young adults diagnosed with these rare CNS embryonal tumors since January 2010. The collected information includes patient details, tumor characteristics, diagnosis and treatment methods, complications, late effects, outcomes, and follow-up data. This large multicenter effort is supported by the Immune Oncology Research Institute and includes patients up to 25 years old. Participants data will be gathered via questionnaires completed by participating centers and national groups. The study measures key outcomes such as 3-year and 5-year overall survival, complete remission rates, and event-free survival at 3 and 5 years. Quality control and data management are overseen by the Immune Oncology Research Institute. The registry will help identify prognostic factors, treatment gaps, and inform future diagnostic and treatment recommendations.