Active clinical trials for "Immunologic Deficiency Syndromes"

The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir, lamivudine q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48. This study has a total duration of 192 weeks, including a 96-week double-blind period and a 96-week open-label period. The present results are based on the first 48 weeks of this ongoing study.

Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).

The purpose of this study is to demonstrate noninferiority (a new treatment is equivalent to standard treatment) in terms of the percentage of patients who have plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks of randomized treatment with tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus TDF/FTC/efavirenz (TDF/FTC/EFV).

HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation, polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent primary immune disorders that are typically fatal without Hematopoietic Cell Transplant (HCT). However, transplant is often complicated by inflammation, infection and other co-morbidities. In addition, these disorders have been shown to be cured with partial chimerism, making them an ideal target for the use of reduced intensity approaches, where a portion of patients may not achieve full donor chimerism, but instead achieve stable mixed chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and unstable chimerism remain challenges. An institutional case series from Cincinnati Children's Hospital demonstrated full or high-level chimerism and improved durable engraftment using intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH as well as other primary immunodeficiencies where allogeneic transplant with RIC has been shown to be feasible and stable chimerism is curative.

The purpose of this study is to evaluate the first web-based cessation program developed expressly for people living with HIV who smoke tobacco. Main study goals are (1) to evaluate the website's feasibility (i.e., recruitment, adherence, retention, and satisfaction) and (2) to complete a prospective, randomized controlled trial comparing the efficacy of the online program to standard care with a primary outcome of 3 month point-prevalence abstinence.

Aging populations experience a decline in adaptive immune system function also known as immunosenesence. Nutritional approaches to stimulate and strengthen the immune system are needed for this growing segment of the population. A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response. Our objective was to examine the immune stimulating effects of dairy protein subjected to ultraviolet radiation (UV-C) radiation treatment process instead of pasteurization. Participants were 21 healthy individuals over 60 years of age who consumed 6 g of the dairy protein or a comparison, soy isoflavone protein, twice a day for eight weeks. DTaP vaccine administered at week 4. Non-parametric t-tests revealed a significant increase in Tetanus antibodies in the dairy group compared to the soy group at week 8. These findings suggest additional benefits of UV-C treated unheated dairy protein as a solution to counteract immunosenescence, but warrant further study in elderly and other populations that might benefit from immune system stimulation.

This is a prospective, non-randomized, single-cohort, longitudinal, single-center, clinical study designed to assess the efficacy and safety of a cryopreserved formulation of OTL-101 (autologous CD34+ hematopoietic stem/progenitor cells transduced ex vivo with EFS (Elongation Factor 1α Short form) Lentiviral Vector (LV) encoding for the human ADA gene) administered to ADA-SCID subjects between the ages of 30 days and 17 years of age, who are not eligible for an Human Leukocyte Antigen (HLA) matched sibling/family donor and meeting the inclusion/exclusion criteria. The OTL-101 product is infused after a minimal interval of at least 24 hours following the completion of reduced intensity conditioning. For subjects who successfully receive the OTL-101 product, pegademase bovine (PEG-ADA) Enzyme Replacement Therapy (ERT) is discontinued at Day+30 (-3/+15) after the transplant. After their discharge from hospital, the subjects will be seen at regular intervals to review their history, perform examinations and draw blood samples to assess immunity and safety.

The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary Immunodeficiency Diseases (PIDD)

DTG 50 milligram (mg) tablet was approved for marketing in Russian Federation; however, DTG is not currently available for subjects at Acquired Immune Deficiency Syndrome (AIDS) Centers as it is not available for order and supply via Federal program. This study is an open-label study which will include subjects, who complete taking DTG in studies ING112276, ING113086, ING114915, ING111762, and those subjects who end participation in study 200304 in which they received either DTG or lopinavir/ritonavir (LPV/RTV). DTG will be supplied at a dose of 50 mg once daily to eligible subjects until the subject stops taking DTG or transitions to commercial supply of DTG when available at AIDS Centers via the Federal program. The objective of this study is to bridge the gap between the closure of ING112276, ING113086, ING114915, ING111762 or end of subject's participation in 200304 and the actual availability of commercial DTG at AIDS Centers via Federal program for human immunodeficiency (HIV)-1-infected adult subjects in Russian Federation. The study will also investigate long-term safety of DTG for subjects continuing DTG in Russian Federation.

Combination antiretroviral therapy (ART, HIV medications) dramatically increases the expected lifespan of HIV (Human Immunodeficiency Virus)infected patients; yet, the risks for cardiovascular disease (CVD), such as heart attacks and stroke, are increased in this population. This increased risk may be linked to persistent inflammation and activation of the immune system. Although the relationship between cardiovascular disease and HIV-infected individuals who are taking HIV medications is not well understood, the team of researchers involved in this study observed that a diet rich in soy, at levels recommended by the FDA (Federal Drug Administration), improved cholesterol levels and inflammation in individuals not infected with HIV. From this study, the researchers hope to gain understanding on how dietary soy will impact HIV-infected individuals who are taking HIV medications. Two pretzels with and without soy developed at OSU (Ohio State University) in the Department of Food Science and Technology and used in previous clinical trials will be used to investigate how the pretzel snacks will affect your cardiovascular disease risk, immunity, and how your body breaks down naturally occurring chemicals from soy.