View clinical trials related to Immunologic Deficiency Syndromes.
Filter by:The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older. The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to [>=]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than [<]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of MK-8510 monotherapy in anti-retroviral-naïve HIV-1 infected participants.
Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions. With a simple blood test, rare genetic conditions can be easily detected, and the early start of transformative treatment will help avoid severe disabilities and increase the quality of life. Baby Detect Project is an innovative NBS program using a panel of target sequencing that aims to identify 126 treatable severe early onset genetic diseases at birth caused by 361 genes. The list of diseases has been established in close collaboration with the Paediatricians of the University Hospital in Liege. The investigators use dedicated dried blood spots collected between the first day and 28 days of life of babies, after a consent sign by parents.
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.
The investigators will examine whether a combination of at-home nucleic acid amplification tests, on-demand telemedicine, and delivery of prescriptions such as Paxlovid quickly after testing positive for COVID-19, can reduce severe outcomes and hospitalization of immunocompromised patients and those who are 65 years and older. They will also analyze whether these efforts lower the cost of care compared to standard of care.
This project will evaluate the impact of including Severe Combined Immunodeficiency into the newborn bloodspot screening panel. It will recruit parents and health professionals primarily from the sites where this new form of screening is being trialled well as additional sites where clinicians will be involved in the care of these babies and comparator groups are needed. The proposed work will consist of two work packages. The first, a mixed-methods study conducted with families from the point of screening information being returned through to the child's fifth birthday. The second, a qualitative interview study conducted with health professionals during the clinical evaluation phase of the national pilot programme.
To date, many studies have focused on the characteristics of PID in children, allowing to highlight an entry into the disease in the context of more or less severe infections in all pediatric departments. However, only one study has so far studied the frequency of these PID in a pediatric resuscitation unit, which is why we propose this study to the Caen University Hospital. Investigtors propose a two-step study, both retrospective and prospective, in order to increase our cohort. The retrospective analysis of the data will be done over the period 2013-2016, the prospective analysis will be done from May 2017 to January 2018. The study will be monocentric, performed in the pediatric resuscitation department of the University Hospital of Caen to evaluate the prevalence of PIDs and describe their characteristics. The included patients will be aged 0 to 18 years, hospitalized in the pediatric intensive care unit for a serious infection and / or of an unfavorable evolution, or an opportunistic germ infection in the absence of a DIP or an immunodeficiency previously known. The inclusion will be proposed by the intensive care pediatricians. Authorization by the legal representative will be required in advance. The data will be collected during the systematic consultation in pediatric haemato-immuno-oncology within 3 months after their hospitalization in intensive care unit to detect a DIP by a thorough interrogation, a clinical examination and a first-line biological assessment. A second consultation will be scheduled in the 3 months following the 1st with announcement of the results of the first balance sheet and completion of a second complementary balance sheet if a suspicion of DIP persists at the end of the first balance sheet. The precise description of the incidence of these immunodeficiencies and their characteristics could lead to the development of recommendations on the routine screening of PID in pediatric resuscitation; an early diagnosis enabling preventive and curative management (vaccine, immunoglobulin, antibiotic prophylaxis, etc.) to be put in place in order to limit the risk of infectious recurrence and reduce the morbidity.
The goal of this community trial is to provide HIV education based on the newly developed HIV education kit (PREM-Kit) and evaluate the knowledge, attitude and practices related to HIV prevention among the late adolescents (aged 18 to 19 years old) in Malaysia. The main question it aims to answer is does the PREM-Kit improve the knowledge, attitude and practices related to HIV prevention among the adolescent? Participants will be asked to: - answer a questionnaire as a baseline screening to determine their knowledge, attitude and practices related to HIV prevention. - Using PREM-Kit, they will participate in a series of health education sessions. There will be three sessions in total which will be delivered two weekly apart. Each of the sessions will take approximately 20 minutes duration. - Following the last session (third session), participants will have to answer the same questionnaire ; once immediately after the last session, once at 3-months post-intervention, and lastly, at 4-months post-intervention. Researchers will compare participants who received the existing Basic Science and Biology module to see if there is any improvement in the knowledge, attitude and practices related to HIV prevention.
To evaluate the usability and utility of the device, % agreement between the PID-RDT and the referent assay (serum/plasma), and % agreement between capillary blood and venous blood samples using the PID-RDT within confirmed PID patients prior to receipt of their monthly IV-Ig treatment.
To address the significant barriers to pre-exposure prophylaxis (PrEP) implementation for cisgender women and address racial inequities in HIV prevention in the United States (US), a novel approach that accounts for multilevel influences is necessary. This study is the second part (Aim 2) of a multi-component project and involves a patient- and clinic-level intervention in a public health family planning clinic in Duval County Florida, where most patients are women of color. The area has one of the highest HIV incidence rates among women in the US. The investigators developed 1) a tablet-based decision support tool (DST) that helps users learn about HIV vulnerabilities and HIV prevention strategies to inform how they consider options for reducing their likelihood of acquiring HIV, and 2) clinic-wide trainings regarding shared decision making and trauma informed care. In Aim 1 (previously completed), participants were randomized to viewing an HIV prevention DST in a clinic that had not received clinic-wide trainings. In Aim 2 (the present study), there will be two phases. In the first phase, participants will receive care at the clinic following training; the DST will not be used. In the second phase, in addition to being seen at a clinic-site that has experienced the training, participants will use the DST before their visit. Participants will be surveyed about experiences with HIV prevention counseling, intentions about using HIV prevention, and DST use (among those in the active arm in the second phase). A subset of participants, individuals who self-identify as Black or Latinx, will also complete a post-clinic visit interview. The investigators will assess whether participants initiated an HIV prevention method three months following their initial visit. The main outcomes will include a quantitative and qualitative assessment of PrEP or other HIV prevention use, decisional certainty, and satisfaction with information about HIV prevention options.