View clinical trials related to Immunologic Deficiency Syndromes.
Filter by:This study is a Phase 2/3, multicenter, double-blind, randomized, parallel-group, placebo-controlled, dose-finding trial of Serostim® (mammalian cell-derived recombinant human growth hormone, r-hGH) versus placebo in subjects with human immunodeficiency virus-associated adipose tissue redistribution syndrome (HARS). The primary study objective is to determine whether Serostim® treatment reduces adipose tissue maldistribution more effectively than placebo. The primary co-endpoints are derived from measures of visceral adipose tissue assessed by computerized tomography (CT) and the ratio of trunk; and limb fat assessed by dual-energy X-Ray absorptiometry (DXA) scans. Anthropometric measures, physical exams, quality of life assessments, serial photographs, and various laboratory measures will be used to address secondary objectives. These secondary objectives relate to the impact of Serostim® on Physician and subject assessments of change in body shape, health-related quality of life, attitude towards medication compliance, metabolic markers, fat redistribution, and safety. On Day 1, eligible subjects will be randomized in a 1:1:1 ratio to receive daily Serostim®, Serostim® and placebo given on alternate days, or daily placebo. Serostim® doses will be based on body weight, with a maximum dose of 4 milligram (mg). Therapy will continue for 12 weeks. Treatment will then be altered and the new treatment will be continued through Week 24. Interim Study Visits will be required at Weeks 2 and 4 (Treatment Period 1) and at Weeks 14 and 16 (Treatment Period 2). Subjects will be offered to be enrolled into a maintenance Protocol (Study 23056) at Week 24.
The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.
The purpose of this study was to determine the effects of nevirapine treatment on the pharmacokinetics of methadone in HIV-1 infected, opioid-dependent adults who had been on a stable methadone maintenance therapy for at least five days prior to study entry.
Our study is a randomized controlled trial that aims to evaluate the effectiveness of modified directly observed therapy (mDOT) to (1) increase both short and long term adherence to HAART treatment, and (2) improve clinical outcomes associated with HAART therapy. Our hypothesis is that modified directly observed therapy (mDOT) during the initial 6 weeks of HAART, supervised primarily by HIV-positive lay activists, will improve adherence and clinical outcomes compared with those that do not have supervised mDOT. We also hypothesize that the benefits of mDOT will be achieved through a variety of mediators that will result from the social interactions the patients will have with the activists. These mediators include improved social support, improved knowledge about HAART, reduced stigma, and improved self-efficacy.
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa in AIDS patients for the treatment of anemia that is a result of the disease and zidovudine (AZT) treatment. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus placebo in AIDS patients for the treatment of anemia that is a result of the disease or a result of zidovudine (AZT) treatment for AIDS. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa versus placebo for the treatment of anemia in AIDS (Acquired Immunodeficiency Syndrome) patients with anemia that is a result of this disease and zidovudine (AZT) treatment. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
This study investigates gene abnormalities in Primary Immune Deficiency(PID) with a goal of improving the diagnosis and treatment of patients. The specific disorders include: 1. X linked hyper IgM Syndrome which is caused by an abnormality in the CD40L gene. 2. NEMO associated immune deficiency which is caused by an abnormality in a gene called NEMO. 3. Common variable immunodeficiency (CVID) which has an unknown genetic basis. 4. Other disorders of immunoglobulin production. This study will: 1. Better characterize the clinical features of CD40 L deficiency and NEMO associated immune deficiency and other related primary immune deficiency syndromes. 2. Determine the frequency of CD40 L and Nemo abnormalities. 3. Determine whether particular abnormalities in these genes are associated with more of less severe illness or with specific symptoms. 4. Explore the basic mechanism by which these altered genes cause immune dysfunction. 5. Identify other genes causing low immune globulin levels and related primary immune deficient states.
This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It will also determine if patients who take this drug show improvement in their symptoms, decrease in inflammatory chemicals in the gut, changes in their immune cells, and improvement in how their gut is functioning to absorb food. Patients between 18 and 75 years of age with CVID and chronic diarrhea or involuntary weight loss of more than 5 percent of their past body weight over the past 12 months may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, blood, urine and stool tests, chest x-rays and skin test for exposure to tuberculosis, and a hydrogen breath test. For the latter, breath samples are collected before and every 20 minutes (for 2 hours) after the subject drinks a sugar solution. This test determines the digestive effects of bacteria in the upper intestine. Samples are collected by having the subject blow into a balloon. Participants undergo the following tests and procedures: Immune System and Gastrointestinal Evaluation - 48-hour stool fat collection (measures the amount of undigested fat in the stool): Subjects keep a diary of what they eat for a 48-hour period. At the beginning of the 48 hours they take two dye capsules and then take another two capsules 48 hours later. They collect a stool sample when they pass the second set of capsules in their bowel movement. An additional 24-hour stool collection is tested for loss of protein in the stool. - D-xylose absorption test (measures the ability of the gut to absorb nutrients): Subjects drink a solution of d-xylose (a sugar substitute). Blood samples are collected before and 1 hour after drinking the solution. - Upper endoscopy: A thin flexible lighted tube is advanced through the mouth to evaluate the esophagus, stomach and beginning of the small intestine. - Lower endoscopy: A thin flexible lighted tube is advanced through the rectum to evaluate the colon. Treatment Period (Study days 1 to 57) - Physical examination - study days 1, 8, 15, 29, 43 and 57 - Blood samples to test the levels of STA-5326 in the blood. On study days 1 and 57, samples are collected before the medication dose and 1, 2, 4, 6 and 8 hours after the dose; on day 29, one sample is collected before the medication dose. - Blood samples for routine safety testing - study days 1, 8, 15, 29, 43 and 57 - Medication history - study days 1, 8, 15, 29, 43 and 57 - Interview about pain, discomfort, and well being - study days 1, 8, 15, 29, 43 and 57 - Pregnancy test for women who can become pregnant - study days 15, 43, and 57 - D-xylose absorption test - study days 29 and 57 - Electrocardiogram - study days 29 and 57 - Urine test - study days 29 and 57 - Blood test for research on immune cells - study day 57 - Repeat endoscopies and studies of gut function (24- and 48-hour stool collections) Follow-up period (Day 85 and day 113) -Physical examination, blood tests, medication history, questions about pain, discomfort and well being