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Immunologic Deficiency Syndromes clinical trials

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NCT ID: NCT02244450 Completed - Clinical trials for Severe Combined Immunodeficiency, Atypical

Generalized Neonatal Screening of Severe Combined Immunodeficiencies

DEPISTREC
Start date: December 2014
Phase: N/A
Study type: Interventional

Severe combined Immunodeficiencies ( SCID ) are a group of inherited diseases of the immune system by characterised profound abnormalities of T cell development . Infants with SCID require prompt clinical response to Prevent life -threatening infection and studies show significantly improved survival in babies Diagnosed at birth as a result of previous family history . SCID follows criteria for population -based newborn screening since it is asymptomatic at birth and fatal within the first year of life, the confirmation of the disease is easy, there is a curative treatment , and it is known that early stem cell transplantation improves survival . Quantification of TRECs (T- cell receptor excision circles ) in DNA extracted from Guthrie samples is a sensitive screening test for Specific and SCID . The investigators propose in this study to perform a neonatal screening of SCID , in a population of 200,000 babies over a period of two years . The investigators propose to study the clinical utility and cost effectiveness ratio, and SCID screening to demonstrate that could result in a broad benefit to Individuals detected , making screening relatively cost-effective in spite of the low incidence of the disease .

NCT ID: NCT02234492 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

The Effects of Statin Therapy on Coronary Flow Reserve and Inflammatory Markers in HIV-Positive Patients

Start date: September 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether the use of rosuvastatin in Human Immunodeficiency Virus (HIV) infected individuals lowers inflammation in blood vessels, improves blood circulation in the small arteries that provide nutrients to the heart muscle and improves neurocognitive function.

NCT ID: NCT02218320 Completed - Clinical trials for Human Immunodeficiency Virus

Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults

Start date: October 2014
Phase:
Study type: Observational

This is a Phase IV, open label, observational study to compare the gastrointestinal tissue concentrations, inflammatory response, and viral replication of two integrase-inhibitors, raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in blood plasma. The study will be comprised of 20 HIV-infected volunteers who will be enrolled equally into two groups. Group A will consist of 10 subjects receiving an antiretroviral regimen of tenofovir, emtricitabine, and raltegravir, and Group B will consist of 10 subjects receiving an antiretroviral regimen of tenofovir, emtricitabine, and dolutegravir. Participants will provide small pieces of tissue, or biopsies, which will be taken from three distinct locations of the large intestine during a colonoscopy procedure. These biopsies will be used to measure the amount of raltegravir or dolutegravir, HIV virus, and inflammatory markers present in the gastrointestinal tract.

NCT ID: NCT02214173 Completed - Clinical trials for Human Immunodeficiency Virus Infection

The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV

BRM4
Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of the nutritional supplement rice bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with HIV. The hypothesis is that there will be a significant improvement in metabolic syndrome and immune variables in HIV-positive participants in the intervention group compared to the control group.

NCT ID: NCT02211690 Completed - Clinical trials for Human Immunodeficiency Virus

The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis

dPEP
Start date: August 2014
Phase: Phase 4
Study type: Interventional

This study aims to describe the proportion of participants with non-occupational post-exposure prophylaxis (NPEP) failure, defined as NPEP non-completion (including loss to follow-up) at week 4 or primary HIV infection at week 4 or 12, excluding those participants who should and do cease study drug because: 1. The participant is found to be HIV-infected (study drugs will be ceased until the genotype of the infecting strain is determined) 2. The source is found to be HIV-uninfected The primary study objectives are: 1. To describe on-drug adherence and regimen completion rates of 28 days of NPEP using dolutegravir (DTG) with co-formulated emtricitabine-tenofovir (FTC-TDF) 2. To describe the safety of 28 days of non-occupational post-exposure prophylaxis (NPEP) using dolutegravir with co-formulated emtricitabine-tenofovir The study is a multi-site, prospective, open-label, non-randomized trial. One-hundred (100) eligible participants will receive dolutegravir (one tablet) with co-formulated emtricitabine-tenofovir, two tablets, once daily for 28 days based on one of the following exposures: 1. receptive anal intercourse with a source known to be HIV-infected; or 2. receptive anal intercourse with a source of unknown HIV status; or 3. insertive anal intercourse with a source known to be HIV-infected There will be 7 study visits over a 12-week period. Follow-up post NPEP is for 8 weeks i.e. to week-12 post-exposure. Any participant who is intolerant of dolutegravir will be managed at the investigator's discretion.

NCT ID: NCT02196831 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Tesamorelin Effects on Liver Fat and Histology in HIV

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis. NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals with increased visceral adiposity generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous study, treatment with tesamorelin in HIV-infected individuals selected for abdominal adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.

NCT ID: NCT02196064 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Hepatitis C Virus (HCV) Coinfected Subjects

Hepatic Safety of Eviplera® in HIV/Hepatitis C (HCV)-Coinfected Patients Without HCV Treatment in the "The HEPAVIR HEPATIC SAFETY Cohort."

hEPAtic
Start date: May 2014
Phase: N/A
Study type: Observational

To evaluate the incidence of grade 3 or 4 transaminase elevations or grade 4 total bilirubin elevations (hepatic toxicity) during the first 48 weeks of antiretroviral therapy with the combination of rilpivirine (25mg), tenofovir (245mg) and emtricitabine (200mg), in a single-tablet regimen (Eviplera®) in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected subjects.

NCT ID: NCT02191215 Completed - Clinical trials for Acquired Immunodeficiency Syndrome

Clinical and Therapeutic Evaluation of the Infection by HIV/AIDS

Start date: June 2003
Phase: N/A
Study type: Observational

The aim of the Post Marketing Study (PMS) is to evaluate the efficacy and safety profile of nevirapine in the management of the HIV/AIDS in an open environment.

NCT ID: NCT02185300 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers

Start date: July 2014
Phase: Phase 1
Study type: Interventional

Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada, Australia and EU. A dispersible tablet has been developed for pediatric use as an alternative to the granule formulation, already in development, and the approved film-coated tablet. This is a single-center, randomized, open-label, 5-way crossover study in healthy adult subjects. The study will evaluate the relative bioavailability of five dosing regimens: 20 mg DTG pediatric granules (Treatment A) and of DTG 20 mg dispersible tablets (DTG 20 mg DT) after dispersed in: low mineral content(LMC) water (Treatment B); dispersed in CONTREX™ mineral water (Treatment C); dispersed in low mineral content water and consumed after standing for 30 minutes (Treatment D) and dispersed in CONTREX mineral water and consumed after standing for 30 minutes (Treatment E). Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug. CONTREX is a trademark of Nestlé Waters Corporation.

NCT ID: NCT02180763 Completed - Clinical trials for Primary Immunodeficiency (PID)

Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

Start date: April 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.