Comuna 5

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are evaluating the long-term use of a long-acting injectable drug called cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in people at risk of acquiring HIV. This study focuses on participants who have completed or are currently enrolled in previous related studies HPTN 083 and HPTN 084 and their sub-studies. The goal is to monitor new HIV infections, serious adverse events, injection site reactions, and other adverse events that might cause withdrawal over an extended period. Participants will receive CAB LA by gluteal intramuscular injection at a dose of 600 mg every 8 weeks. This treatment continues from the parent studies, and participants will be followed for up to approximately 3 years. The study includes ongoing treatment with CAB LA and regular assessments to evaluate safety and effectiveness as part of this long-term follow-up. During the study, participants will undergo regular HIV testing, safety monitoring, and evaluation of injection site reactions and adverse events. Researchers will track the number of new HIV infections and detailed characteristics of these infections from the start of the study through the follow-up period. This includes monitoring serious and grade 3 or 4 injection site reactions, as well as other adverse events that may lead to withdrawal from the study. Participants will be observed closely to ensure continued safety throughout the study duration.