View clinical trials related to Immunologic Deficiency Syndromes.
Filter by:The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing. The study aims to: To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population. To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results). To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.
The goal of this observational study is to determine the incidence and spectrum of opportunistic infections among Chinese HIV/AIDS patients at this stage, to find intervention targets, to construct an early warning prediction model, and to give an individualized program with integrated immune function to obtain salvage opportunities for patients.The main questions it aims to answer are: - Describe the populations and characteristics of pathogenic microorganisms involved in HIV co-infection, map the spatial and temporal changes in the infection system of pathogenic microorganisms, and evaluate their impact on disease regression. - Explore the mechanism of interaction between pathogenic microorganisms and host autoimmune deficiencies. - Discover early warning and predictive markers and immunological indicators of pathogenic microorganisms, and explore new technologies and programs to reduce the mortality rate of infection.
The Human Immunodeficiency Virus (HIV) epidemic persists in France, with approximately 6000 new cases per year. Various prevention tools against HIV exist, including condoms, regular testing, Post-Exposure Prophylaxis (PEP), HIV treatment for seropositive partners, single-use disposable injection equipment for drug use and pre-exposure prophylaxis (PrEP). Continuous or on-demand PrEP with tenofovir disoproxil fumarate/emtricitabine has proven effective in reducing the risk of HIV infection. France was the first European country to authorize PrEP, leading to an unprecedented impact on seropositivity discovery rates in 2018, with a 7% decrease in new infections compared to 2017. However, the effectiveness of PrEP can be hindered by challenges in retaining users within the healthcare system. According to the EPIPHARE report, which has been monitoring Truvada® or generic PrEP use since 2017, a substantial proportion of new users do not receive PrEP renewal in the first 6 months after initiation. Such early interruptions, increasing in frequency, affected around a quarter of individuals who initiated PrEP in the second half of 2021. A recent study reported that these early interruptions have a significant detrimental impact on PrEP effectiveness in real life, especially among those under 30 years old and in socio-economic precarious situations. The main barriers to PrEP adherence are multifactorial, including social precarity, limited PrEP access, and a low perception of HIV risk. To address this, in France, general practitioners have been authorized to issue initial PrEP prescriptions since June 1, 2021. The future challenge is to increase PrEP use and optimize retention to combat the HIV epidemic, relying significantly on general medicine. The goal of our study is to broaden PrEP access by optimizing its initial prescription in general medicine and to assess user retention in PrEP care through the established partnership between general practitioners and patients. The research will be conducted in collaboration between Saint Louis Hospital in the 10th arrondissement of Paris and general practitioners willing to participate in the study, located in the 3rd, 10th, 11th, 13th, and 19th arrondissements. Participating general practitioners may be in private practice, employed in health centers, or working in health houses. As part of the study, general practitioners will receive training from the infectious diseases department of Saint-Louis and Lariboisière hospitals. This training will be both theoretical and practical, with the opportunity to attend initiation and follow-up PrEP consultations in the department. A dedicated phone line in the infectious diseases department of Saint Louis Hospital will be available for participating general practitioners seeking specialized advice. They will be encouraged to register as PrEP prescribers in their appointment scheduling software. Patients will be informed of the study objectives and its process by the general practitioner, and their oral non-opposition will be collected. Each inclusion consultation will last approximately 20-40 minutes, allowing the general practitioner to prescribe PrEP, conduct the usual care consultation, and collect clinical, demographic, socio-economic, lifestyle, medical history, and patient vaccination data on a dedicated data collection form. The follow-up duration will be two years, with consultation frequency matching that of regular PrEP follow-ups, and data collection will occur at M6, M12, M18, and M24 using a dedicated data collection form. Data collected during inclusion and follow-up consultations will be anonymized and integrated into the electronic Clinical Report Form. During each PrEP consultation (initiation and follow-up), general practitioners will provide patients with a PrEP prescription if the pre-PrEP biology report allows it (according to HAS (Haute Autorité de Santé) recommendations). For patients who have not been attending consultations, a telephone survey will be offered to inquire about PrEP continuation and collect information on follow-up or reasons for stopping PrEP.
To evaluate the safety, efficacy and pharmacokinetic properties of Boya's IVIG preparation in participants with PID aged less than 60 years and more than 6 years.
This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year old) sexual minority men and transgender and gender diverse teens (ASMM/TGD). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).
The increase in the practice of running has encouraged a proliferation of studies evaluating the impact of this sport on health. A number of these studies have looked at the influence of endurance events on the immune system. After prolonged exercise, a systemic inflammatory syndrome sets in, with repercussions for the functioning of the immune system. The number of lymphocytes in the blood is reduced, the function of natural killer (NK) cells is impaired and secretory immunity is impaired. During this period of immunosuppression, often referred to as the 'open window', the host may be more susceptible to micro-organisms that bypass the first line of defence. The invetigators' hypothesis is therefore that ultratrailers are overexposed to the risk of infection due to immunodepression resulting from practising this sport. In order to support this hypothesis, the investigators would like to look at infectious complications in general and ear-nose and throat episodes (rhinitis, pharyngitis, laryngitis, etc.) in particular, which are the most common infections encountered in primary care, along with urinary tract infections.
To evaluate the safety, efficacy, and pharmacokinetic properties of Shu Yang intravenous immune globulin in patients with primary immune deficiency aged less than 60 years. The main benefit of IVIG is to help the body fight against a large variety of infections generally associated with morbidity and mortality in patients with primary immunodeficiency diseases, particularly in CVID and XLA. In addition, a decrease in the number of infections, a reduction in medications and hospitalizations, and a better quality of life are expected. Throughout treatment, approximately one-fourth of persons may experience a side effect. These are usually mild or bothersome but not dangerous. Very rarely, more serious side effects like allergic reactions or low blood counts (anemia) can occur. One of the most common side effects is headache. Other side effects include chills, fever, flushing, flu-like muscle pains or joint pains, feeling tired, nausea, vomiting, and rash. For the most part, these reactions typically happen with the first dose of IVIG or because change to a different brand of IVIG. All IVIG products have similar warnings and contraindications, such as the potential for renal failure, thrombotic events, aseptic meningitis, hemolysis, and anaphylactic reactions.
The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035). After the first TAK-881 infusion in study TAK-881-3002, the dosing interval and/or the dose of TAK-881 can be adjusted by the study doctor to every 2, 3 or 4 weeks at scheduled site visits, Participants will visit the clinic every 12 weeks until the End of Study (EOS) visit.
Case-control diagnostic accuracy study with 130 potential pediatric PID+ (primary immunodeficiency) patients, and 100 age-matched, healthy controls (PID-). The potential PID+ participants will be recruited prospectively through 9 hospitals in Sindh and Punjab states or contacted via the PID surveillance registry developed by AKU Hospital's Polio Excretion in PID study to identify children with primary antibody deficiency (PAD+: a type of PID+); healthy, age-matched PID-participants will be recruited by snowball sampling. At the point of care, health care workers (HCWs) will collect capillary blood samples (0.1mL) to run the PID rapid screening test and reader on potential PID+ participants (identified by exhibiting >2 of the Jeffrey Modell warning signs) and healthy, age-matched controls. All pediatric study participants will be sent to the hospital lab to have a confirmatory immunology panel (see 4.4.1 Diagnosing PID for the battery of tests) run on a serum/plasma sample to confirm their PID diagnosis (PID+/PAD-, PID+/PAD+, PID-); a 1.5uL aliquot of serum/plasma will simultaneously be used to run a PID rapid screening test by a laboratory technician (LT). HCWs and LTs will be blinded to true PID status. Blood and serum PID rapid screening test results will be compared to the confirmatory immunology panel to determine diagnostic accuracy. All clinical management of study participants will follow the standard of care for PID in Pakistan and will be based upon the immunology panel result. The HCWs and LTs administering the tests will be trained prior to the diagnostic accuracy test (see Objectives below) and will provide feedback on the tool post-training and post-use to assess usability, acceptability, and feasibility of integrating the test and digital reader into tertiary hospitals for the purpose of improved national PID surveillance, improved PID patient care, and polio eradication in Pakistan.
In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.