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Immunologic Deficiency Syndromes clinical trials

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NCT ID: NCT02343666 Withdrawn - Clinical trials for Stage IV Adult Hodgkin Lymphoma

HIV-Resistant Gene Modified Stem Cells and Chemotherapy in Treating Patients With Lymphoma With HIV Infection

Start date: August 15, 2016
Phase: Phase 1
Study type: Interventional

This pilot phase I trial studies the side effects and best dose of human immunodeficiency virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are then re-infused into the patient. These genetically modified stem cells may help the body make cells that are resistant to HIV infection.

NCT ID: NCT02257788 Withdrawn - HIV Clinical Trials

PRO 140 for Human Immunodeficiency Virus Infection

Start date: September 2014
Phase: Phase 2
Study type: Interventional

PRO 140 2103 is a multicenter, randomized parallel group study, conducted in male and female adult subjects infected with CCR5-tropic HIV-1.

NCT ID: NCT02177760 Withdrawn - Clinical trials for Severe Combined Immunodeficiency

Sirolimus Prophylaxis for aGVHD in TME SCID

Start date: July 2014
Phase: Phase 2
Study type: Interventional

Study Design: SCID infants receiving an unconditioned haploidentical transplant will be started on Sirolimus (0.05 mg/kg/day) day -5 for Acute Graft-Versus-Host Disease (aGVHD) prophylaxis. Sirolimus levels will be monitored with goal sirolimus trough level of 5-8 ng/mL. Patients will be monitored for signs of aGVHD as defined by UCSF SOP CL 221.06 through day +100. Sirolimus will be tapered once T-regulatory cell to CD4 effector cell ratio is > or = 9%. Setting: Inpatient BMT Unit Benioff Children's Hospital at UCSF Medical Center Study Subjects: 15 infants with diagnosis of maternally engrafted T cells SCID by CA Newborn screen receiving unconditioned haploidentical HSCT Main Outcome Measures: Incidence of aGVHD (dermatitis, hepatitis, enteritis) as defined by SOP CL 221.06 by Day +100. Hypothesis 1. Patients placed on sirolimus prophylaxis will have lower incidence of aGVHD compared to historical controls. Hypothesis 2. Lower doses of sirolimus milligram per kilogram will be required to maintain goal troughs of 5-8 ng/mL.

NCT ID: NCT01793506 Withdrawn - Immunodeficiencies Clinical Trials

Novel Testing Procedures

Start date: April 2016
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate a novel screening test to detect patients with primary immunodeficiencies(PIDs). The investigators plan to use information gained from this study in order to advance the field of clinical immunology, thus improving the diagnosis, treatment, and well-being of future patients. The purpose of this study is to determine if this screening test is able to detect patients with immune problems, and the investigators will test patients with known PIDs to determine if the test is accurate The investigators hypothesize that detecting serum immunoglobulins from dried blood spots will be effective in detecting patients with known primary immunodeficiencies. If our hypothesis is confirmed, it opens the possibility of using point of care testing to screen for primary immune deficiencies. Age of study subjects will range from 1 year to 80 years of age, and will be recruited form the Immunodeficiency clinic at the Medical College of Wisconsin/Children's Hospital of Wisconsin (MCW/CHW). Any subject having testing done to evaluate the immune system is eligible for this study. This will include patients with known PIDs as well as patients evaluated for a suspected immunodeficiency. It is anticipated that 150 subjects will be analyzed over a two year period.

NCT ID: NCT01738555 Withdrawn - Clinical trials for Human Immunodeficiency Virus Infection

A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects

Start date: April 2013
Phase: Phase 2
Study type: Interventional

This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks. Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.

NCT ID: NCT01726348 Withdrawn - Clinical trials for Human Immunodeficiency Virus-Type 1

A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients

Start date: January 2014
Phase: Phase 4
Study type: Observational

The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.

NCT ID: NCT01692470 Withdrawn - Clinical trials for Human Immunodeficiency Virus Type 1 (HIV-1) Infection

A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection

Start date: June 2013
Phase: Phase 4
Study type: Observational

The purpose of this study is to assess the safety and effectiveness of rilpivirine hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human immunodeficiency virus type 1 (HIV-1) infection.

NCT ID: NCT01283100 Withdrawn - Clinical trials for Infection, Human Immunodeficiency Virus I

A Drug Interaction Study Evaluating Plasma GSK2248761 and GSK1349572 Pharmacokinetics in Healthy Adult Subjects.

Start date: March 2011
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, three-period, fixed-sequence cross over study in healthy adult subjects. A total of approximately 16 healthy subjects will be enrolled to provide data from 12 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will be the day after Day 5 of Period 2.

NCT ID: NCT01273103 Withdrawn - Clinical trials for Infection, Human Immunodeficiency Virus

A Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK2248761 Administered as an Oral Suspension to Healthy Adult Subjects

Start date: January 2011
Phase: Phase 1
Study type: Interventional

This study is a Phase I, open-label, single dose, mass balance study in a cohort of 6 healthy adult male subjects. The study will consist of: Screening evaluations, a treatment phase, and follow-up evaluations. In the treatment phase, after an overnight fast of at least 10 hours, each subject will receive a single oral suspension dose of GSK2248761 200mg containing [14C] - GSK2248761. Following dosing, serial whole blood, plasma, urine, and fecal samples will be collected. Subjects will be required to remain in the unit until the radiocarbon excreted falls to less than or equal to 1% of the administered dose for two consecutive 24-hour collections in both urine and feces, whichever occurs first. Safety will be assessed by vital signs, 12-lead electrocardiogram (ECG), clinical laboratory tests, AE monitoring, and physical examinations as indicated.

NCT ID: NCT01173510 Withdrawn - HIV Infections Clinical Trials

A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells

Start date: August 23, 2010
Phase: Phase 4
Study type: Interventional

Human Immunodeficiency Virus (HIV) infection is permanently established by integrating a deoxyribonucleic acid (DNA) copy into the human chromosome, a step also necessary to complete the Human Immunodeficiency Virus (HIV)replication cycle. Standard treatment of HIV infection suppresses Human Immunodeficiency Virus (HIV)replication and has not been able to eliminate Human Immunodeficiency Virus (HIV)from an infected person because of the integrated Human Immunodeficiency Virus (HIV). Raltegravir (RAL), the first approved antiretroviral (ARV) in a new class called integrase inhibitors, works by preventing integration of Human Immunodeficiency Virus (HIV). For participants with Human Immunodeficiency Virus (HIV)who have never taken antiretroviral medications, this research study will test whether Raltegravir (RAL), a recommended first-line ARV, can eliminate Human Immunodeficiency Virus (HIV)from key immune system cells.