View clinical trials related to Immunologic Deficiency Syndromes.
Filter by:Background: HIV stands for human immunodeficiency virus, which is the virus that causes AIDS. There is currently no licensed vaccine to prevent HIV infection. Researchers want to test a vaccine called Trimer 4571 for the first time. It was made at the National Institutes of Health (NIH) and contains no HIV. The vaccine is mixed with a substance called alum and injected in the arm. Alum is included to boost the body's immune response to the vaccine. It has been used in licensed vaccines for over 60 years and has been found to be safe. Objectives: To see if the vaccine Trimer 4571 is safe, well-tolerated, and to study immune responses to it. Eligibility: Healthy adults ages 18-50 years Design: Participants were screened with a physical exam and blood tests. They agreed to not become pregnant and to avoid behavior that would put them at high-risk for HIV infection during the study. Participants had about 15 study visits over about 9 months. The first 6 participants received a low dose of the vaccine mixed with alum. Once the low dose was deemed safe, 10 new participants were allocated to receive a higher dose. All participants were randomly assigned to get the vaccine by injection in a muscle or under the skin. All participants received a total of 3 vaccine injections over 20 weeks. Each visit where participants received the vaccine lasted about 5 hours. Participants were watched after each injection. Participants who were able to get pregnant would have a pregnancy test before each injection. Participants received a thermometer and recorded their temperature and symptoms every day for 1 week after each injection. The injection site was checked for redness, swelling, or bruising. At follow-up visits, participants had blood drawn and checked for health changes or problems. Follow up visits lasted about 1-2 hours.
HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%. Risk factors; maternal viral load, breastfeeding, vaginal birth, and prematurity. Although there is a high rate of false positivity in prenatal screening in our country, one of the factors affecting this is the number of pregnancies.
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 <18 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.
While advances in medication have led to greatly improved outcomes for people living with HIV/AIDS, less than one-third of all people living with the disease are adherent enough to their medication to achieve viral suppression. Alcohol consumption has been shown to have a significant effect on HIV medication adherence, so the proposed research will aim to reduce alcohol use among people living with HIV/AIDS through a technology-driven intervention. This eight-session intervention will be delivered using a combination of videoconferencing, smart phones, and Bluetooth-enabled breathalyzers for monitoring of alcohol consumption, with an overall goal of reducing alcohol use, mitigating adherence issues, and achieving optimal prevention and treatment responses for people living with HIV/AIDS.
Patients with chronic lymphocytic leukemia (CLL) are at increased risk of infections as compared to age matched controls, with infections being a major cause of morbidity and mortality. Previous studies have shown that patients with CLL have both hypogammaglobinemia and impaired humoral immunity as defined by vaccine responses to both polysaccharide and peptide antigens. Attempts at decreasing infections in CLL have included therapy with prophylactic antibiotics and intravenous immunoglobulin. In general clinical practice and in previous studies, patients have started IV immunoglobulin replacement therapy if they have a history of serious infection or hypogammaglobinemia (defined as Immunoglobulin G below 500-600 g/dL), but vaccine responses have not been evaluated. This study will identify CLL patients with humoral immunodeficiency by checking both Ig levels and vaccines responses. In patients with impaired humoral immunity, the investigators will use subcutaneous immunoglobulin replacement to show this intervention will increase Ig levels, protective antibody titers, and be well tolerated.
This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.
- Background/Rationale: Epidemiological data about Primary Immunodeficiency Disorders (PIDD) in Kuwait is needed to better understand peculiarities and to compare them with other regions and ethnicity. - Study hypothesis: PIDD is relatively common in Kuwait compared to populations from different geographic areas. The distribution of PIDD in Kuwait is different from other geographic areas with more severe forms being more frequent. - Brief inclusion and exclusion criteria of study participants: PIDD patients presented at different clinics/hospital in Kuwait. Patients with secondary immunodeficiencies (drug induced, virus induced, and immunodeficiency associated with metabolic disorders... ect), will be excluded - Estimated sample size of the study: All patients who were registered in KNPIDR since 2004 will be included in the study along with the new patients who will be recruited during the study period. - Primary objectives: - Determine the prevalence and frequency of different PIDD in Kuwait - Identify clinical presentation patterns for PIDD in Kuwait - Identify natural history of PIDD in Kuwait - Help to asses epidemiology of PIDD in Kuwait - Determine particularities about PIDD affecting the population in Kuwait - Determine the health impact of PIDD in Kuwait - Development of strategies to improve the care and the quality of life of patients with PIDD
Oral pre-exposure prophylaxis (PrEP) has been proven effective in reducing HIV infection in high-risk men who have sex with men, heterosexually active women and men, and injecting drug users. Despite its 2012 approval by the FDA and the development of Centers for Disease Control and Prevention (CDC) clinical guidelines, PrEP uptake has been limited. Significant impediments to PrEP implementation include: system barriers (lack of a medical "home" and of models for implementing PrEP); provider barriers (difficulty identifying those likely to benefit from PrEP, inexperience with PrEP, and concerns about adherence and risk compensation); and user barriers (lack of awareness of PrEP, inability to access providers comfortable with prescribing PrEP, and concerns about stigma and side effects). Cost is not a barrier in New York State, where PrEP is covered by many insurance plans, including Medicaid. Primary Care for PrEP (PC4PrEP) is a structural, multilevel intervention that will integrate PrEP into primary care practices that care for underserved communities in the Bronx, NY, an epicenter of continuing HIV infection in the US. PC4PrEP will develop an organizational protocol for prescribing PrEP in primary care; identify high-risk individuals in primary care clinics and community HIV testing sites using a new PrEP Eligibility Tool; link them to primary care providers (PCPs) who can provide PrEP; and counsel potential users about PrEP both before they receive a prescription (to enhance receptivity), and after they initiate PrEP (to enhance adherence). In the course of this study, investigator(s) will (1) develop and pilot PC4PrEP; (2) implement and evaluate it in "real-world" settings (Federally Qualified Health Centers; FQHCs) on objective outcomes as well as provider and patient reports; and (3) present a new model, the PrEP Cascade that - as with the HIV Care Cascade for HIV+ populations - may be used to evaluate the impact of PrEP programs in the US and other countries. PC4PrEP is consistent with CDC and New York State Department of Health (NYSDOH) Guidelines and the Affordable Care Act in integrating PrEP into primary care practices and is responsive to recent 2014 NYSDOH recommendations which now position PrEP as a first-line intervention for MSM and transgender women who engage in ongoing anal sex without condoms, HIV- partners in sero-discordant relationships, and high-risk heterosexual women in high seroprevalence areas.There are two Specific Aims: (1) Finalize the PC4PrEP intervention and, in a clinic-randomized Phase 2 futility trial, assess whether it shows promise for increasing PrEP prescription rates in the Bronx, NY; and (2) Identify strengths and limitations of PC4PrEP in two ways: (a) through a mixed-methods process evaluation PrEP-eligible patients and PCPs, counselors and navigators; and (b) by identifying "fall-off" at each step of the PrEP Cascade.
This study will evaluate the anti-retroviral activity of MK-8527 in HIV-1 infected, ART-naïve participants. The primary hypothesis is that MK-8527 has superior anti-retroviral activity compared to placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) at 168 hours postdose.
Thiotepa is a chemotherapy drug used extensively in bone marrow transplantation. Thiotepa is a prodrug that undergoes metabolic conversion in the liver by CYP2B6 and CYP3A4 to its primary active metabolite, triethylene phosphoramide (TEPA). The goal of this study is to determine what causes some children to have different drug concentrations of thiotepa and TEPA in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that certain clinical and genetic factors cause changes in thiotepa and TEPA drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.