Immunodeficiency

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

This study evaluates whether a mobile phone-based mHealth Behavioural Change Communication BCC educational intervention can improve the adoption and exclusive use of Liquid Petroleum Gas LPG for cooking among households in semi-rural Bangladesh. Household air pollutants HAP from biomass fuels such as wood, agricultural residue, and cow dung expose almost 3 billion people worldwide, including 89% of people in Bangladesh. In the earlier GEOHealth study, 24 months of LPG use reduced personal PM2.5 exposure by about 58.2% and produced changes in innate immune and inflammatory responses, while chronic cardio-pulmonary markers remained relatively stable. More than 70% of households continued using LPG after the earlier study, although not exclusively. The investigators will conduct a large household-level randomized controlled trial using an mHealth-based educational intervention and will continue following the cohort. The study will examine the long-term effects of HAP reduction on subclinical measures of cardiovascular and pulmonary dysfunction, innate and inflammatory immune function, and antibody response to vaccines. Personal 24-hour and area-wise 5-day exposure to PM2.5 and black carbon will be repeatedly assessed before and after the intervention. Lung function and lung pathology will be assessed using spirometry, Chest X-ray, and high-resolution computed tomography of the chest. Cardiovascular measures will include blood pressure and EKG, while metabolic dysfunction will be assessed using HbA1c and fasting lipid profile. Immune function will be evaluated through immune cell phenotyping, functional cytotoxic killer cells, and oxidative stress of lymphocytes.

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 01 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the programs acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the interventions goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

Researchers are studying HIV-1 infected adults who are currently on a stable triple drug regimen to see how switching to a dual therapy affects the virus and immune system. This trial compares dual therapy with dolutegravir and lamivudine DTG3TC, Dovato against a triple regimen with bictegravir, tenofovir alafenamide, and emtricitabine BICTAFFTC, Biktarvy. The main goal is to check if the dual therapy is not worse than the triple therapy in terms of the amount of intact HIV virus in blood cells after 48 weeks, while monitoring immune activation and inflammation markers. Participants will be randomly assigned to either continue their triple therapy or to switch to dual therapy. The study includes a 48-week primary period and extends up to 240 weeks to assess longer-term effects. Researchers will measure viral sequences, immune system markers, metabolic health indicators like weight and insulin resistance, and body composition using scans such as DXA and FibroScan. Patient experiences will also be evaluated through questionnaires. During the study, participants will attend regular visits for blood sample collection and assessments of viral load, immune function, metabolic health, and liver condition. These include measuring markers like interleukin-6, C-reactive protein, T cell activation and exhaustion indicators, and others. The study aims to ensure safety and monitor any health complications over nearly five years. Participants must agree to ongoing blood sample storage for research and complete scheduled assessments throughout the study.

Researchers are evaluating a community health worker-delivered mental health counseling intervention delivered remotely via a mobile health app to reduce anxiety and depression among people living with HIV in Florida. This pilot randomized controlled trial aims to assess the preliminary effectiveness of this adapted positive affect counseling approach compared to the standard version of the app and usual mental health care. The study is sponsored by the University of Florida and focuses on improving mental health outcomes in this population. Participants will be randomly assigned to one of two groups. The intervention group will receive approximately five weekly 60-minute individual counseling sessions via secure video calls through a modified PositiveLinks app that includes enhanced mental health resources. If symptoms do not improve, participants may be referred to a licensed mental health professional. The control group will use the standard PositiveLinks app, which provides feedback on anxiety and depression symptoms and a list of local mental health resources without counseling. During the study, data will be collected from participants electronic medical records and the app for about six months after enrollment. Researchers will measure changes in anxiety and depression levels at three months as primary outcomes. Participants will provide informed consent before joining, and there is no masking or blinding in the trial. The study will monitor mental health symptoms and the use of counseling through app data and medical records to evaluate the interventions preliminary effectiveness.

Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.

Researchers are evaluating the safety of Immune Globulin Subcutaneous Human, 20% Solution in people with primary immunodeficiency disease PID using a retrospective medical database in Japan called PIDJ2. This observational study collects information about patients who have received this treatment as part of routine care to better understand potential adverse events. The study is sponsored by Takeda and uses existing patient registry data to assess safety outcomes. Participants included in this study are those with PID who have received Immune Globulin Subcutaneous Human 20% infusion following the official package instructions. The study does not administer treatments but analyzes data from the PIDJ2 database collected between January 24, 2024, and January 23, 2029. It focuses on patients whose records include details about use of the study drug and documented adverse events. During the study, researchers will review the database to identify any participants who experienced specific adverse events such as anaphylactic reactions, thromboembolism, or aseptic meningitis up to five years from the initial registration or first dose. The study involves no direct visits or interventions, as it is based on reviewing existing records. The total study period extends until March 31, 2030, allowing long-term safety observations.

Researchers are conducting a first-in-human phase 1 trial to study OX118, a human monoclonal antibody targeting OX40 ligand, in healthy adults aged 18 to 60 years. The trial aims to evaluate the safety, tolerability, and how the body processes OX118 when given as a single intravenous dose. This study involves 32 healthy volunteers with a body mass index between 18.5 and 30.0. Participants are divided into five groups receiving different single doses of OX118 or a placebo by intravenous infusion. The doses range from 0.1 mgkg to 10 mgkg, with participants randomized to receive either the drug or placebo based on a pre-arranged schedule. The trial includes sentinel dosing for initial participants in each group, and all participants stay at the clinic for at least 24 hours after dosing for monitoring. Each participant will attend 7 clinic visits over about 91 days, including a 28-day screening period. Visits include treatment administration, safety assessments such as vital signs, ECGs, physical exams, laboratory tests, and monitoring for adverse events. Safety data is reviewed by an internal committee before moving to the next dosing group. Researchers will measure adverse events, vital signs, lab results, ECG changes, and physical exam findings from Day 1 to Day 63, along with drug concentration and immune response data.

Researchers are conducting a long-term observational study to understand the outcomes of people living with HIV who have participated in previous HIV-NAT trials. This study aims to provide insights into the long-term safety and durability of different antiretroviral treatments, the effectiveness of HIV viral load and CD4 cell counts in predicting disease progression and mortality, and the impact of adherence to treatment. It also seeks to explore various complications and quality of life over an extended period. The study follows participants who were previously or are currently involved in HIV-NAT trials, collecting and evaluating ongoing clinical outcomes. It assesses long-term consequences related to different antiretroviral drug classes, including risks of metabolic issues like lipodystrophy, resistance patterns, and effects on various body systems such as cardiovascular, renal, and hepatic functions. The study also monitors opportunistic infections or malignancies among co-infected patients and evaluates immune recovery and quality of life. Participants provide written consent and their health is monitored over a period that can extend up to 30 years. The study involves regular evaluations of clinical outcomes, adherence to medication, and quality of life assessments. Researchers analyze data to better understand long-term effects and disease progression in HIV, helping to inform future treatment approaches and patient care strategies.