Mtubatuba

This research evaluates the safety, tolerability, and immune response of the GRAdHIVNE1 vaccine, a gorilla adenovirus vectored vaccine designed with networked epitopes. It is a Phase 1 randomized, double-blind, placebo-controlled, dose-ranging trial involving healthy adults living without HIV and adults living with HIV in Southern Africa. The study builds on previous trials and animal studies showing that strong CD8+ T cell responses are essential to control HIV, aiming to inform vaccine development for both prevention and treatment purposes. Participants will receive either a low or high dose of the GRAdHIVNE1 vaccine or a placebo. The study allows simultaneous enrollment into both dose groups. The intervention is administered to both people living without HIV and those with HIV who meet specific immune and treatment criteria. This dose-ranging approach helps assess different levels of vaccine exposure to evaluate safety and immune effects. During the study, participants will be closely monitored for safety and vaccine tolerance, including assessments of adverse events for up to 28 days and serious adverse events for 19 months. The trial includes regular follow-ups and clinical evaluations, with immunogenicity and viral suppression status tracked for people living with HIV. The total participation period covers initial dosing and extended safety observation, ensuring comprehensive data collection on vaccine effects and participant well-being.

Researchers are evaluating the effectiveness of budesonide/formoterol inhalers compared to standard asthma treatments in children and adolescents aged 6 to 18 years who have asthma or are newly diagnosed with asthma. This Phase 3 randomized controlled trial aims to reduce asthma exacerbations over a 52-week period. The study addresses the high burden of asthma in South Africa, where asthma is common in childhood and poses significant health and economic challenges, especially in low-income settings. The trial seeks to provide new evidence on the best treatment approach for asthma management in children and adolescents in this region. Participants will be randomly assigned to one of two groups: one group will use budesonide/formoterol inhalers both as needed for symptom relief and for regular anti-inflammatory maintenance, with dosing based on age (80/4.5 mcg for ages 6-11 and 160/4.5 mcg for ages 12-18). The other group will receive the standard care, which includes separate inhalers for symptom relief (salbutamol) and maintenance therapy with inhaled corticosteroids or other asthma medications as prescribed by their doctors. The study includes telephonic follow-ups at weeks 13 and 39 and in-person visits at weeks 26 and 52. During the 52-week study, researchers will track the number of asthma exacerbations, record any clinic or hospital admissions, and monitor medication changes and adverse events. Participants will complete scheduled assessments including lung function tests and symptom monitoring. Safety will be overseen by an independent Data and Safety Monitoring Board and a Trial Steering Committee to ensure the study is conducted properly and safely. The trial will generate important data on asthma control and treatment effectiveness in this population over one year.

Researchers are evaluating how peer support and long-acting injectable antiretroviral therapy (ART) affect viral suppression and staying in care for adolescents living with HIV in South Africa. This study focuses on young people aged 12 to under 19 who know their HIV status and have been on ART for at least six months. The goal is to help adolescents transition into adult care with better health outcomes. The study has two stages. In Stage 1, peer navigation support—including education, appointment reminders, adherence help, sexual and reproductive health guidance, and healthcare navigation—is tested in a stepped-wedge, cluster-randomized trial across 12 clinics over 18 to 24 months. Preferences for the use of long-acting injectable ART are also explored, along with cost and public health impact analyses. Stage 2 includes an individually randomized trial within some clinics to evaluate the injectable ART over an 18-month period. Participants will attend about 5 to 7 visits over two years. Researchers will collect data on viral suppression and retention in care to assess the effectiveness of peer navigation. Additional evaluations include user and stakeholder feedback, economic assessments, and program impact. The study includes follow-up for up to 30 months to monitor the sustainability of the interventions.

Researchers are evaluating liraglutide combined with lifestyle counseling for managing obesity in adults living with HIV who are on dolutegravir-based antiretroviral therapy (ART) and have a body mass index (BMI) of 30 kg/m2 or higher. This study focuses on people living with HIV in South Africa, where obesity and metabolic diseases are increasing concerns, especially among those on newer ART regimens associated with weight gain. The research aims to address the limited data on the use of liraglutide for obesity management in this population. Participants will start liraglutide injections at 0.6 mg daily, increasing weekly by 0.6 mg until reaching 3.0 mg daily by week 5. This dose will be maintained for 8 weeks, followed by 12 weeks without the drug. Along with medication, participants receive counseling on diet and physical activity throughout the study. This single-arm, open-label study includes a 12-week treatment phase and a 12-week follow-up phase without medication. During the study, researchers will monitor body weight, cardiometabolic health, and various patient-reported outcomes related to diet, exercise, sleep, and quality of life. They will assess participant adherence to treatment, retention rates at 12 and 24 weeks, and acceptability of liraglutide through interviews. Basic cardiometabolic lab tests will also be performed regularly to track health changes over the 24-week study duration.

Researchers are conducting a Phase 3, double-blinded, placebo-controlled, multicenter trial to assess whether azithromycin taken as a preventive treatment can reduce death rates in adults with advanced HIV disease. Participants eligible for the study must have confirmed HIV infection with low CD4 counts or specific treatment histories, reflecting advanced immunosuppression. The trial aims to better understand mortality outcomes related to this preventive approach in this population. Participants will be randomly assigned to receive either azithromycin tablets or placebo tablets for 28 days. All participants will be followed for 24 weeks after randomization to measure the main outcome of death from any cause, with total follow-up lasting 48 weeks. The study compares the effects of azithromycin prophylaxis against an inactive placebo to evaluate its impact on survival. During the study, participants will be monitored regularly to track health outcomes, particularly mortality. They must be able to start or adjust antiretroviral therapy within four weeks of joining the trial. Researchers will closely observe for any adverse effects, treatment adherence, and overall health status throughout the follow-up period to assess the safety and effectiveness of the intervention.