Plettenberg Bay

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the steady state pharmacokinetics, safety, and tolerability of doravirine (DOR) when given to pediatric participants with HIV-1 infection aged 4 weeks to less than 12 years and weighing under 45 kg. Participants may be treatment-naive or virologically suppressed on stable combination antiretroviral therapy (cART) with no history of treatment failure. This phase 2, single-group, open-label, multi-site study aims to assess DOR either with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) or as part of a fixed-dose combination with lamivudine (3TC) and tenofovir disproxil fumarate (TDF). Participants receive oral doravirine combined with 2 NRTIs or as part of the fixed-dose combination DOR/3TC/TDF. The study includes a treatment period up to Week 24 to monitor pharmacokinetics and safety. Those who complete the Week 96 visit may join an extension study to continue receiving DOR until it becomes commercially available or for up to an additional 224 weeks, whichever occurs first. Throughout the study, participants undergo intensive pharmacokinetic sampling at designated timepoints up to 12 or 24 hours postdose to measure drug concentration and absorption parameters. Safety and tolerability are assessed through monitoring adverse events, laboratory tests, and clinical evaluations up to 24 weeks. Participants are closely observed for viral suppression status and any drug-related side effects during treatment and extension periods.

Researchers are evaluating whether the drug zilebesiran can reduce the risk of major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, or heart failure in adults who have hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This Phase 3 global study is designed to continue until enough cardiovascular events have occurred to assess the treatment's effect. Participants will be randomly assigned to receive either zilebesiran or a placebo, both given as injections under the skin (subcutaneous administration). All participants will continue with their standard care, which includes treatment with at least two antihypertensive medications, one of which must be a diuretic such as a thiazide or loop diuretic. The study is double-blind, so neither participants nor researchers know who is receiving the active drug or placebo. During the study, participants will be closely monitored for cardiovascular events including heart attacks, strokes, heart failure hospitalizations, and cardiovascular deaths over approximately five years. Researchers will collect data on these events to determine the time until the first occurrence of any of these outcomes. Safety assessments and standard clinical evaluations will also be performed throughout the study period to ensure participant well-being.