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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Tuberculosis (TB) is a serious infectious disease causing millions of cases and deaths globally, with a high burden in developing countries like Nigeria. TB mainly affects young adults and is worsened by HIV infection. Current TB treatments are long and challenging, leading to poor compliance and drug resistance. Researchers are studying whether atorvastatin, a cholesterol-lowering drug, can improve TB treatment by making the bacteria more vulnerable and reducing lung damage. Previous Phase II studies showed atorvastatin to be safe and possibly effective, warranting further investigation in this Phase IIC trial. This trial is a multicenter, randomized, open-label study comparing four treatment arms: standard TB drugs alone or combined with daily atorvastatin at doses of 20 mg, 40 mg, or 60 mg for 16 weeks. All participants receive standard anti-TB treatment for 24 weeks. The study will evaluate safety, how quickly the bacteria disappear from sputum, improvements in chest X-rays, and lung function. Participants will be followed closely for 12 months after starting treatment. Participants aged 12 to 65 with confirmed pulmonary TB will have multiple assessments including sputum tests, blood tests, lung function and chest X-rays at various points during and after treatment. Researchers will monitor safety by recording any serious side effects and will measure treatment effectiveness by the time to stable bacterial clearance and disease-free survival at six months. This extended follow-up aims to provide detailed data to support future larger trials.
Actively Recruiting
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.