Zaria

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.

Researchers are evaluating the pharmacokinetics and pharmacodynamics of atorvastatin at different doses combined with standard first-line treatment for adults with drug-sensitive pulmonary tuberculosis. This sub-study of the ATORTUB trial aims to identify an optimal atorvastatin dosing regimen to support pulmonary tuberculosis treatment. The study is a Phase 2 pharmacokinetics-pharmacodynamics dose-finding trial involving adults aged 12 years and older. Participants will be randomly assigned to one of four groups. All will receive the standard tuberculosis treatment regimen of rifampin, isoniazid, pyrazinamide, and ethambutol for 8 weeks followed by rifampin and isoniazid for 16 weeks. Additionally, three groups will receive daily oral atorvastatin at doses of 20 mg, 40 mg, or 60 mg for the first 16 weeks. The total treatment duration is 24 weeks, followed by a 6-month follow-up period, making total participation last 52 weeks. Throughout the study, participants will attend multiple visits for sputum collection, chest X-rays, lung function tests, and blood sampling to measure pharmacokinetic parameters of atorvastatin and the anti-TB drugs. Blood samples will be taken on day 14 and weeks 8, 16, and 24 after randomization to assess drug concentrations and metabolism. Researchers will monitor safety, treatment adherence, and lung health, with data used to develop a pharmacokinetic/pharmacodynamic model for future dosing recommendations.

Benign prostatic hyperplasia (BPH) is a common condition affecting men, especially as they age, with up to 90% of men experiencing it by age 80. This research aims to create an ongoing international registry to collect and analyze demographic and clinical data from men with BPH who receive either medical therapy or surgical treatments. The registry helps track treatment patterns and outcomes worldwide to better understand the effectiveness and complications related to various BPH treatments. The registry collects detailed baseline information including patient-reported symptoms, sexual health, quality of life, urinary flow, and laboratory values such as prostate-specific antigen and testosterone. It also records any complications like bleeding, infections, incontinence, strictures, ejaculation issues, and erectile dysfunction. This data is gathered over a three-year period with no set endpoint, allowing for long-term follow-up and analysis of real-world treatment results. Participants provide medical records which are securely stored and accessed only by authorized users. The study monitors symptoms using standardized scores and quality of life measures, along with clinical tests such as post-void residual urine volume. Regular audits ensure data accuracy, and the registry’s technology supports future integration with patient portals and electronic medical records. The study duration is planned for at least three years, with possible extensions to continue follow-up and research.

Researchers are studying how genetic factors, especially the degree of African ancestry, and environmental factors affect the benefits and side effects of maintenance treatment in women with ovarian cancer. This study focuses on an investigational drug called niraparib, which is being tested for ovarian cancer treatment. Niraparib works by preventing cancer cells from repairing damaged genes, making it harder for these cells to grow and spread. Niraparib will be given as oral tablets daily at one of three dose levels (100mg, 200mg, or 300mg) based on each participant's weight, platelet count, and other health conditions assessed at the start of the study. This is a single-arm, prospective, multicenter study evaluating the safety, tolerability, and metabolism of niraparib as maintenance therapy following front-line treatment in women of African ancestry with ovarian cancer. Participants will provide saliva and/or blood samples and tumor tissue specimens for genetic analysis. They will be monitored for safety and side effects for up to three years, including the occurrence of common and severe adverse events previously reported. Throughout the study, participants will complete quality of life and patient-reported outcome measures to assess the impact of treatment.

Researchers are investigating how genetic modifiers influence hemoglobinopathies, including sickle cell disease and beta-thalassemia. These diseases vary widely in severity, and while some genetic factors have been identified, more are believed to exist that impact disease outcomes. This large-scale, multi-ethnic genome-wide association study (GWAS) aims to discover new genetic modifiers, validate known ones, pool existing genetic data, standardize disease descriptions, and develop risk scores to better classify patients. The study will perform GWAS using SNP chips on blood samples collected during routine clinical visits or existing biobank DNA samples. Participants with various hemoglobinopathy genotypes will be included without restrictions on gender or ethnicity. The research will analyze genetic factors related to survival, complications like stroke, renal impairment, pain syndromes, and responses to treatments such as hydroxyurea and iron chelation. Data collected will contribute to a comprehensive research resource combining genomic, phenotypic, and functional information. Participants will provide consent and contribute blood samples if DNA is not already available. Researchers will gather worldwide demographic and clinical data from multiple centers. The primary outcome measured over five years is the identification of genetic modifiers influencing disease traits and treatment responses. This extensive monitoring and data collection aim to improve understanding and risk stratification of hemoglobinopathies globally.