Mtubatuba

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 HIV-1. This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is more effective than a daily standard pre-exposure prophylaxis PrEP in preventing HIV-1 infection in women. The study also monitors the safety and tolerability of MK-8527 compared to standard treatment. Participants are randomly assigned to one of two groups one group receives 11 mg of MK-8527 once monthly along with a placebo daily pill resembling EmtricitabineTenofovir Disoproxil Fumarate FTCTDF, and the other group receives the daily FTCTDF pill plus a monthly placebo resembling MK-8527. This treatment phase lasts for up to approximately two years. Afterward, all participants take open-label FTCTDF daily for an additional 28 days. During the study, participants attend regular visits for up to about two years, during which researchers check for new HIV-1 infections, record any adverse events or side effects, and monitor if participants stop the study medication due to side effects. The primary outcomes include the number of participants who acquire HIV-1 infection, those who experience adverse events, and those who discontinue due to adverse events, all tracked over the treatment period.

Researchers are conducting a Phase 1 trial to study the GRAdHIVNE1 vaccine, which uses a gorilla adenovirus vector to target HIV. The study aims to evaluate the vaccines safety, tolerability, and ability to stimulate immune responses in healthy adults both living with and without HIV. This trial builds on earlier vaccine research and preclinical studies that highlighted the importance of broad T-cell responses for controlling HIVs diversity and immune evasion. Participants living without HIV will be randomly assigned to receive either one or two doses of the GRAdHIVNE1 vaccine at two possible dose levels or a placebo. Those living with HIV will receive either two doses of the vaccine or placebo. The vaccine doses studied are 5x1010 or 2x1011 units. The study uses a double-blind design to compare vaccine effects with placebo. Throughout the study, participants will be closely monitored for safety and side effects over several timeframes including 7 days, 28 days, and up to 19 months. Immune responses will be measured repeatedly for up to 19 months to assess the vaccines impact. Participants will complete follow-up visits to evaluate adverse events, immune function, and overall health status during the trial period.

This research aims to evaluate the effectiveness of budesonideformoterol inhalers compared to the standard asthma treatments in reducing asthma flare-ups over one year in children and adolescents aged 6 to 18 years with mild to moderate asthma. The study focuses on participants who have had at least one asthma exacerbation in the past year and is conducted as a Phase 3 randomized controlled trial at a single center. The trial addresses the high burden of asthma in South African children and adolescents and seeks to provide evidence for improved, affordable treatment approaches in low- and middle-income countries. Participants are randomly assigned to one of two groups one group receives budesonideformoterol inhalers at doses adjusted by age and symptom severity, used both for symptom relief and maintenance the other group continues with the standard care involving separate inhalers for relief and maintenance, prescribed by their doctors. The budesonideformoterol is delivered via inhalers with doses of 804.5 for children aged 6-11 and 1604.5 for those 12-18 years, taken as needed or twice daily depending on control. The study lasts 52 weeks, with visits at 13, 26, 39, and 52 weeks, including telephone follow-ups to monitor asthma attacks and medication changes. Throughout the study, participants undergo lung function tests, including peak flow measurements and bronchodilator reversibility testing, to confirm asthma diagnosis and monitor control. Researchers collect data on asthma exacerbations, hospital or clinic admissions, adverse events, and medication adjustments. Safety and trial conduct are overseen by independent expert committees. The main outcome is the number of asthma exacerbations over 52 weeks, with cost-effectiveness also evaluated. Participants and their families are supported and followed for the full year duration of the trial.

Researchers are evaluating the impact of peer navigation support and long-acting injectable antiretroviral therapy ART on viral suppression and retention in care among adolescents living with HIV in South Africa. The study focuses on adolescents aged 12 to under 19 who are aware of their HIV status and have been receiving ART for at least six months. This research aims to help adolescents transition into adult care more effectively through psychosocial support and healthcare navigation. The study has two stages Stage 1 is a stepped-wedge, cluster-randomized trial conducted over 18 to 24 months across 12 clinics to assess the effectiveness of peer navigation. It also includes evaluating user preferences for long-acting injectable ART, economic analyses, and a public health program evaluation. Stage 2 is an individually randomized trial within some clinics to assess long-acting injectable ART in adolescents. Participants receive peer navigation support including HIV education, appointment reminders, adherence assistance, and sexual and reproductive health support. Participants are involved for about two years, with 5 to 7 visits. During this time, the research team evaluates viral suppression and retention at 18 months, then follows participants for an additional 12 months to assess sustainability. They also assess acceptability of injectable ART and perform economic and cost-effectiveness analyses. The study includes regular monitoring through visits and assessments to understand both the behavioral and treatment-related outcomes in this adolescent population.

Researchers are evaluating whether taking azithromycin as a preventive treatment can reduce the risk of death in adults with advanced HIV disease. This is a Phase 3, double-blind, placebo-controlled trial involving multiple centers. The study aims to understand if azithromycin prophylaxis can lower mortality compared to a placebo in this vulnerable population. Participants will be randomly assigned to receive either an oral azithromycin tablet or a matching placebo tablet once daily for 28 days. After this treatment period, they will be followed for 24 weeks to measure the main outcome of all-cause mortality. The total study participation will last 48 weeks to monitor both short-term and longer-term effects. During the study, participants will undergo assessments to track survival and hospitalizations at 12 and 24 weeks after starting the treatment. Researchers will closely monitor health outcomes and any hospital stays to evaluate the impact of azithromycin prophylaxis. Safety and adherence will be followed throughout the trial to ensure accurate measurement of results.