Leon De Los Aldama

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.

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the short-term and long-term safety and effectiveness of belimumab in adults diagnosed with early systemic lupus erythematosus (SLE) who have positive autoantibodies and continue to have active disease despite stable initial treatment. This phase 4, prospective, open-label study aims to describe how belimumab works in this specific group over a three-year period. Participants will receive belimumab (GSK1550188) administered by subcutaneous injection. There is one treatment arm where all participants will receive this drug. The study lasts for three years, during which participants will be regularly monitored to assess disease activity and treatment safety. During the study, participants will undergo various assessments including clinical evaluations to measure disease activity, laboratory tests, and questionnaires to track health status. The main outcome is the percentage of participants who achieve Lupus Low Disease Activity State (LLDAS) by week 52. Safety and efficacy will be closely monitored throughout the study period, with follow-up visits and evaluations scheduled at regular intervals.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the safety and effectiveness of tulisokibart, a humanized monoclonal antibody, in people with moderately to severely active Crohn's disease. The research includes two studies: Study 1, which has induction and maintenance treatment phases, and Study 2, which only includes induction treatment. The main goals are to see if tulisokibart can help participants achieve clinical remission and endoscopic response compared to placebo, measured at 12 and 52 weeks depending on the study and region (US/FDA or EU/EMA).

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

This research aims to identify complications in children with diabetes mellitus and to compare their clinical, body measurements, and biochemical characteristics across different types of diabetes. Diabetes mellitus is a condition marked by high blood sugar caused by issues in insulin production or how the body uses insulin. The study focuses on how factors causing the disease influence its progression and the development of long-term complications. The study does not involve specific treatments or interventions but follows a group of Mexican children diagnosed with diabetes mellitus. It observes their health over time to understand the disease's evolution and its effects. Participants will have regular evaluations including yearly checks for microalbuminuria and assessments of diabetic retinopathy, cognitive function, intelligence quotient, peripheral neuropathy, nerve damage, and cardiac function at specified years. These comprehensive assessments help monitor disease complications and progression over up to five years.

Researchers are investigating the effects of dapagliflozin and semaglutide on inflammation in patients who have experienced acute ST-segment elevation myocardial infarction (STEMI). Inflammation plays a key role in the development and complications of coronary artery disease and heart attacks, impacting outcomes both immediately and over time. While some treatments reduce inflammation, the use of these antidiabetic drugs after heart attacks has mainly been studied in experimental settings, with limited clinical evidence so far. This open-label pilot study will compare two drugs: dapagliflozin given as a 10 mg oral tablet daily for 24 weeks, and semaglutide starting at 3 mg and gradually increasing to 14 mg daily over the same period. Patients eligible for the study are adults diagnosed with STEMI, with or without type 2 diabetes, clinical obesity, and elevated inflammation markers. Inflammatory markers like high-sensitivity CRP and interleukin 6 will be measured at admission and after 24 weeks of treatment. Participants will undergo standard STEMI care including percutaneous coronary intervention, and their medication use, adherence, and tolerability will be closely monitored throughout the 24-week treatment period. The primary outcomes focus on changes in inflammatory markers at 24 weeks to assess the potential impact of these drugs on heart inflammation after myocardial infarction.

Researchers are evaluating the effects of low-intensity transcranial magnetic stimulation (TMS) on adults aged 18 to 60 with major depressive disorder (MDD). This trial aims to determine whether low-intensity TMS can reduce depressive symptoms and alter levels of the serotonin metabolite 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). The study also monitors potential adverse effects of the treatment. This is a randomized clinical trial including phases 1 and 2. Participants will receive either low-intensity TMS or a sham (placebo) TMS treatment. The active treatment involves 4 days of sessions, with 5 daily treatments lasting 200 seconds each, separated by 10-minute intervals. The magnetic field intensity used is between 2 and 4 milliTesla at a frequency of 50 Hz delivered in theta bursts. The control group receives simulated TMS without magnetic field induction. Blood samples will be taken before and after the intervention to measure 5-HIAA and BDNF levels. During the study, participants will undergo initial clinical assessments to confirm diagnosis and health status. Symptoms of depression will be monitored daily throughout the 4-day intervention and again one month after completion to measure improvement. Blood samples and clinical evaluations will be repeated at the end of treatment. Safety and any adverse effects will be closely observed during and after the intervention to assess the treatment's tolerability and impact.