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Immunologic Deficiency Syndromes clinical trials

View clinical trials related to Immunologic Deficiency Syndromes.

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NCT ID: NCT00903682 Completed - HIV Clinical Trials

A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients

SENSE
Start date: June 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.

NCT ID: NCT00896051 Completed - HIV Infections Clinical Trials

TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients

Start date: August 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics (how the body absorbs, distributes, metabolizes and eliminates a drug) (PK) of ETR when given with ATV/rtv and 1 NRTI in treatment experienced HIV-1 infected patients. In addition, safety, tolerability and anti-HIV effect of this regimen will also be studied. A total of 46 patients will be enrolled.

NCT ID: NCT00895271 Enrolling by invitation - Clinical trials for Primary Immunodeficiency

Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders

Start date: June 10, 2009
Phase:
Study type: Observational

Background: - National Institutes of Health (NIH) researchers have been studying immune cells (white blood cells) to better understand how the human body s defense system works and adjusts or regulates itself, and how changes in this system can make a person sick. - To study the cells of patients who have problems with their immune systems, researchers would like to collect samples of skin cells from patients with immune system disorders and compare them with skin cells taken from healthy volunteers. By studying these cells, researchers hope to determine whether these cells can be modified to create a new kind of personalized gene therapy that would attempt to cure immune diseases in the future. Objectives: - To obtain skin cells from patients with immune system disorders and from healthy volunteers for research and comparison purposes. Eligibility: - Patients between the ages of 2 and 85 who have immune system disorders. - Healthy volunteers between the ages of 18 and 85. - Both groups will be selected from the eligible participants of existing NIH studies into immune system disorders. Design: - Researchers may take up to two biopsies from participants arms, legs, abdomen, or back. - The biopsy site will be numbed with local anesthetic and cleaned before the sample is taken. - The punch skin biopsy needle will be inserted into the skin and rotated to remove a small circle of skin (approximately 1/4 to 3/8 of an inch across). The area will be closed with bandages or stitches, and then covered with a dressing. Any stitches will be removed in 7 to 10 days. - Tissue samples collected in the study will be stored for future research.

NCT ID: NCT00888446 Completed - HIV Infections Clinical Trials

Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid

TGC14F
Start date: October 2005
Phase: Phase 2
Study type: Interventional

This phase 2 study will evaluate the safety, immunogenicity and optimal timing of two injections at three dose levels of the tgAAC09 vaccine in healthy volunteers. Study volunteers will receive two intramuscular injections of tgAAC09 or placebo at Months 0 and 6 (groups A, C, E and G) or at Months 0 and 12 (groups B, D and F) and be followed for a total of 18 months following the first injection with the exception of group G in which volunteers will be followed for 12 months after the first injection (6 months after the second injection). This study will explore whether boosting is possible, and compare a shorter and more practical six-month time interval with a twelve-month time interval.

NCT ID: NCT00872417 Not yet recruiting - HIV Infections Clinical Trials

Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients

Start date: March 2009
Phase: Phase 4
Study type: Interventional

This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take the first line or second line of antiviral therapy. This study aims to set up a well-trained clinical and laboratory team in China, to explore the effects and side-effects of the first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy, cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese generic ARV regiments and effective drug concentrations and to explore primary and secondary drug resistance in China and the immune reconstitution characters of long term ARV in Chinese adult AIDS patients. This study might provide more practical and optimizing prove for the treatment guideline for resource limited areas.

NCT ID: NCT00871078 Completed - HIV Infections Clinical Trials

Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients

Start date: June 2008
Phase: N/A
Study type: Observational

The purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry (FDT).

NCT ID: NCT00858923 Enrolling by invitation - HIV Infections Clinical Trials

Safety Study of the HemoModulator System for the Treatment of Patients With Human Immunodeficiency Virus (HIV)

Start date: July 2008
Phase: Phase 1
Study type: Interventional

Tulane University Health Sciences Center/Louisiana Community AIDS Research Center Program, New Orleans, LA is seeking patients for an HIV study. The purpose of the study is to test the safety and effectiveness of an experimental ultra-violet light device designed to reduce virus in your blood.

NCT ID: NCT00857298 Completed - HIV Infections Clinical Trials

Effect of Diet-induced Weight Loss on HIV-associated Metabolic Syndrome

Start date: February 2009
Phase: N/A
Study type: Interventional

Obese HIV-positive women with Metabolic Syndrome (HIV-MS) and obese HIV-negative women with Metabolic Syndrome will be studied before and after achieving moderate (6%-8%) diet-induced weight loss. The investigators hypothesize that health markers will improve in both groups but that the improvement will be blunted in the women with HIV-MS.

NCT ID: NCT00852943 Active, not recruiting - Immune Deficiency Clinical Trials

Screening Protocol for Genetic Diseases of Allergic Inflammation

Start date: November 2, 2010
Phase:
Study type: Observational

Background: - Mast cells are responsible for most symptoms of allergic reactions. In some allergic diseases, it is unusually easy to cause mast cells to release their contents and cause allergic reactions. In other cases, mast cells grow abnormally and, in rare cases, can result in tumors. Mast cells also control other parts of the immune system. - Understanding why mast cells behave abnormally in allergic diseases is important to finding better ways for diagnosing and treating these potentially life-threatening disorders. Objectives: - To screen mast cells at the genetic and functional levels to characterize abnormalities, identify mutations, detect carrier states, and/or develop therapies for such disorders. - To create a library of information about inherited diseases of mast cell homeostasis and activation, including piebaldism (problems with skin and hair pigmentation), anaphylaxis (severe allergic reaction), allergies, asthma, atopic dermatitis (eczema), allergic rhinitis ( hay fever ), food allergies, urticaria/angioedema (hives/swelling), immunodeficiency diseases, and autoimmune diseases. Eligibility: - Patients between the ages of 1 and 80 years who have been referred by a physician and are known to have or be suspected of having an inherited disorder of mast cells, in particular patients (and their relatives) with piebaldism, allergies, or anaphylaxis that is not caused by allergies. Design: - Study population will consist of up to 1000 participants in a 5-year period. One third of the study population will consist of patients; the other two thirds will consist of biological relatives. - Evaluation is limited to testing on blood specimens; no treatment will be provided. - Clinical and research laboratory evaluations of patients will include the following: - Clinical evaluation and previous laboratory tests as documented in outside medical records by health care providers. A standard questionnaire will also be administered at the time of subject enrollment. - Blood collection for clinical laboratory testing, tailored to each subject s clinical evaluation where appropriate (5 ml). - Blood collection for research laboratory testing, tailored to each subject s clinical evaluation including genetic screening and assessment of mast cell growth and functioning and storage of additional frozen blood specimens for future studies (up to an additional 30 ml). - Evaluations of blood relatives will include the following: - Clinical evaluation as documented from outside medical records by health care providers and administration of a standard questionnaire. - Blood collection where indicated for diagnostic or research purposes. - After 12 consecutive months on the study, results from initial evaluation will be reviewed. Subjects with findings deemed to be of continued interest will be contacted and invited to remain as active participants to this protocol for another year, provided that they renew their consent to participate.

NCT ID: NCT00845416 Completed - Clinical trials for Severe Combined Immunodeficiency

Newborn Screening for Severe Combined Immunodeficiency (SCID) in a High-Risk Population

Start date: March 2009
Phase: N/A
Study type: Observational

The goal of the proposed research is to establish the validity of a newborn screening method for severe combined immunodeficiency (SCID). The assay to be used is developed on the basis of PCR quantification of T-cell receptor excision circles (TRECs) that is absent in SCID patients, thus correlating with the disease