There are about 2348 clinical studies being (or have been) conducted in South Africa. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.
TB is the biggest killer of South Africans. HIV-positive people are at higher risk of getting TB and get much sicker than HIV-negative people when they have TB. However, if TB can be quickly and correctly diagnosed, a treatment plan can be put in place to cure the disease earlier. TB is increasingly diagnosed using the GeneXpert platform, which can be used for a variety of tests (not just TB). HIV viral load monitoring is required at least annually in patients on ART to detect failure of virologic suppression, however, most HIV VL testing is done in a central lab. If a patient has virologic failure, they are more likely to get TB). We wish to see if Xpert Ultra (a new but hitherto unevaluated TB test) done at the clinic results in faster patient TB diagnosis and treatment initiation compared to sending specimens away to a central laboratory. Xpert Ultra, which is a more sensitive next generation version of the World Health Organization improved Xpert MTB/RIF test, is expected to result in the largest incremental improvement in sensitivity in patients who have paucibacillary disease (~100 CFU/ml) who are thus likely to be missed by Xpert MTB/RIF but not Xpert Ultra. In a different patient group (PLHIV returning for their HIV treatment monitoring), we wish to see if POC Xpert HIV-1 viral load (Xpert VL) monitoring results in faster patient viral load quantification compared to sending patient specimens to a centralised laboratory. Both POC tests will use the same testing hardware. This polyvalent utility of the GeneXpert system is hitherto uninvestigated in our setting. We will approach newly diagnosed HIV positive patients coming into the clinic for the first time ART and ask them to be a part of this study. If they agree, we will randomly assign patients to Ultra TB testing done at the clinic or the normal off-site laboratory TB testing. We will record how long it takes for patients to get diagnosed for TB and how long it takes for patients to start their TB drugs. We will approach a different group of HIV positive patients (on ART) returning to the clinic for annual ART follow-up visits and ask them to be a part of this study. If they agree, we will randomly select patients for Xpert VL testing done at the clinic or the normal off-site laboratory TB testing. We will record how long it takes for patients to get their viral load monitored, how long it takes for patients to get their ART regimen adjusted, or receive adherence counselling, or received HIV drug susceptibility testing, if the patient's viral loads are found to be higher than anticipated and considered by the clinical to indicate a lack of viral suppression. This project will confirm if Ultra TB testing performs well in PLHIV irrespective of symptoms, and may produce evidence that supports universal TB testing in this important and vulnerable patient group. We will also assess whether POC placement of Ultra and Xpert VL has benefits (e.g., more patients diagnosed for TB or VL monitored during the same day visit).
The present international, multi-center, open-label, single-arm study aims at collecting clinical safety, tolerability and efficacy data with the use of everolimus combined with exemestane in the Novartis Oncology Emerging Growth Market (EGM) countries for the treatment of post-menopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitor (NSAI) therapy.
The overall goal of this exploratory proof-of-concept study is to determine whether, in participants with pulmonary tuberculosis caused by M. tuberculosis (MTB) with or without rifampin resistance-conferring rpoB-gene mutations, the combination of meropenem and amoxicillin/clavulanate with rifampin has greater early bactericidal activity (EBA) than the combination of meropenem and amoxicillin/clavulanate without rifampin.
TB kills most people with HIV in Africa. TB is out of control. Radically different approaches to deal with the disease is therefor needed. It is known that intensified case finding works in high HIV prevalence environments. However, the poor performance of conventional diagnostics makes the strategy costly and unpalatable for policy makers. If it can be shown that a package of new diagnostic technologies significantly enhances ease and speed of diagnosis, and time to treatment initiation when using intensified case finding, this will usher the way for further studies and policy adjustments to tackle TB. Thus, the work, if found to be useful, could have major policy implications The purpose of this study will be to determine the diagnostic yield, impact and feasibility of community-based intensified TB case finding using symptom screening, point-of-care TB testing (Xpert Omni), point-of-care HIV testing and CD4 count (Alere PIMA), if HIV-infected, together with a clinic-based diagnostic package (sputum smear microscopy, MGIT sputum culture, and digital chest radiograph). Additionally, the study will assess the infectiousness of previously undiagnosed TB cases in the community using cough aerosol sampling technology (CASS) and will determine the genomic, transcriptomic and lipidomic profile of TB isolates from patients undergoing CASS sampling. The cost-effectiveness of using a novel TB diagnostic platform (Xpert Omni) for intensified case finding compared to conventional methods will also be evaluated. ~6000 people will be screened to enrol 600 participants with suspected TB. It is expected that using the GeneXpert® Omni POC mobile clinic of 2- to 3-person team of healthcare workers in an inexpensive panel van will substantially reduce the time to treatment initiation, and the proportion of individuals initiating and completing TB treatment. Investigators will also review and follow up Household contacts of active TB participants. As part of the study investigators will also contribute data and specimens to the RePORT consortium (Regional Prospective Observational Research for Tuberculosis), that aims to create a multinational bank with the primary objective of providing specimens and data to RePORT consortia biomarker researchers and their collaborators over the next decade to achieve a better understanding of the prognosis of TB disease; and the pathogenesis of progression from TB exposure to disease.
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.
The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.