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Immunologic Deficiency Syndromes clinical trials

View clinical trials related to Immunologic Deficiency Syndromes.

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NCT ID: NCT02028338 Completed - Clinical trials for Human Immunodeficiency Virus

Study of Dapivirine Vaginal Ring (VR) in Adolescents

Start date: June 27, 2014
Phase: Phase 2
Study type: Interventional

To assess the safety of dapivirine (25 mg) administered via a silicone vaginal ring in HIV-uninfected adolescent females, when inserted once every 4 weeks during 24-week of study product use.

NCT ID: NCT02027714 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Enhanced HIV Prevention in Couples: Feasibility Study #1

EPIC
Start date: April 2011
Phase: N/A
Study type: Observational

The purpose of this study is to gather information needed to develop a large prevention trial to decrease the risk for HIV transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIVnegative) in Lesotho. The protocol team would like to learn more about men, women and couples in Lesotho and what they think about various topics related to HIV, including HIV testing and counseling, male circumcision and HIV treatment. There will be three parts to the study including 1) a survey 2) focus group discussions; and 3) in-depth interviews. Two hundred pregnant or recently postpartum women will be recruited to participate in the survey. Women who answer the questionnaire will also be asked to participate in the focus groups. A total of 6-8 groups consisting of 6-12 women each will be conducted. Thirty men from the community will be recruited to participate in an in-depth individual interview.

NCT ID: NCT02027519 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Enhanced HIV Prevention in Couples: Feasibility Study #3

EPIC
Start date: December 2013
Phase: N/A
Study type: Observational

The purpose of this study is to gather information needed to develop a large prevention trial to decrease risk for Human Immunodeficiency Virus (HIV) transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho. The protocol team would like to explore new strategies for increasing the number of partners who receive an HIV test and whether this increase in testing also results in identifying HIV-discordant couples. These couples would be the focus of the future large prevention trial, therefore it is critical that the protocol team explore effective strategies for identifying and recruiting these couples. Men and women (index participants) who are attending Antenatal Care (ANC),Tuberculosis (TB) and antiretroviral therapy (ART) clinics will be recruited for this study. If they agree to take part, a testing team will visit their household and offer all adults staying in the house the opportunity to conduct a self-test for HIV. Seventy-five index participants will be enrolled into the study and have their homes visited by the testing team. The number of household members tested will depend on the number of people living in each household.

NCT ID: NCT02027480 Completed - Tuberculosis Clinical Trials

Antiretroviral Therapy and Inflammatory and Coagulation Biomarkers: iMACS Study

iMACS
Start date: March 2014
Phase: N/A
Study type: Observational

The aim of this study is to develop and follow a cohort of human immunodeficiency virus (HIV)-infected adults who are starting HIV drugs at health facilities in Kenya. Blood and urine samples will be collected from all participants in order to establish a sample bank of samples in order to further the understanding of the levels of inflammatory biomarkers and coagulation biomarkers in African patients and the effect of taking HIV drugs on these biomarkers. This study will enroll and follow 685 men and women who are starting HIV drugs and collect blood and urine specimens from them at 4 study visits. These samples will be frozen and stored for future testing related to inflammatory and coagulation biomarkers.

NCT ID: NCT02027454 Completed - Clinical trials for Infection, Human Immunodeficiency Virus

Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction

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

This study is being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Therefore, this study will evaluate the effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead continuous digital data in healthy adults. This study will evaluate the effect of three doses of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. This study consists of three treatment periods (each separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last dosing. The total duration of study including follow-up visit will be approximately 62 days. Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical assessments.

NCT ID: NCT02027441 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Enhanced Prevention in Couples: Feasibility Study #2

EPIC
Start date: September 2012
Phase: N/A
Study type: Observational

The purpose of this study is to gather information needed to develop a large prevention trial to decrease risk for Human immunodeficiency virus (HIV) transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho. The protocol team would like to explore new strategies for increasing the number of partners who receive an HIV test and whether this increase in testing also results in identifying HIV-discordant couples. These couples would be the focus of the future large prevention trial therefore it is critical that the protocol team explore effective strategies for identifying and recruiting these couples. Men and women (index participants) who are attending antenatal (ANC) and Tuberculosis (TB) clinics will be recruited for this study. If they agree to take part, a testing team will visit their household and offer all adults staying in the house the opportunity to receive an HIV test. Three hundred index participants will be enrolled into the study and have their homes visited by the testing team. The number of household members tested will depend on the number of people living in each household.

NCT ID: NCT02016924 Recruiting - HIV Infections Clinical Trials

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Start date: January 16, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to < 18 years) with HIV.

NCT ID: NCT02007642 Completed - Clinical trials for Immunodeficiency and Suspected Infection

Evaluation of High Throughput Sequencing for Screening of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.

PATHOQUEST1
Start date: October 2013
Phase: N/A
Study type: Observational

The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease. The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach. The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.

NCT ID: NCT01998633 Completed - Clinical trials for Chronic Granulomatous Disease

Reduced Intensity Conditioning for Hemophagocytic Syndromes or Selected Primary Immune Deficiencies (BMT CTN 1204)

RICHI
Start date: December 2013
Phase: Phase 2
Study type: Interventional

HLH, HLH-related disorders, Chronic Granulomatous (CGD), HIGM1, Immune dysregulation, polyendocrinopathy, enteropathy, and X-linked inheritance (IPEX) and severe LAD-I represent primary immune disorders that are typically fatal without Hematopoietic Cell Transplant (HCT). However, transplant is often complicated by inflammation, infection and other co-morbidities. In addition, these disorders have been shown to be cured with partial chimerism, making them an ideal target for the use of reduced intensity approaches, where a portion of patients may not achieve full donor chimerism, but instead achieve stable mixed chimerism. Reduced-intensity conditioning strategies have demonstrated improved survival with decreased Treatment Related Mortality (TRM) in institutional series for patients with HLH (Cooper et al., 2006; Marsh et al., 2010; Marsh et al., 2011). However, graft loss and unstable chimerism remain challenges. An institutional case series from Cincinnati Children's Hospital demonstrated full or high-level chimerism and improved durable engraftment using intermediate (Day -14) timing alemtuzumab (Marsh et al., 2013b). This study aims to test the efficacy of the Intermediate RIC strategy in a prospective multi-center study including HLH as well as other primary immunodeficiencies where allogeneic transplant with RIC has been shown to be feasible and stable chimerism is curative.

NCT ID: NCT01997359 Completed - Clinical trials for Human Immunodeficiency Virus (HIV)

Multi-level Determinants of Starting ART Late: Aim 3

LSTART
Start date: June 2012
Phase: N/A
Study type: Observational [Patient Registry]

The availability of HIV care and treatment programs is increasing in sub-Saharan Africa. However more than half the patients who need HIV treatment are still not receiving antiretroviral therapy (ART). This can lead to early death from AIDS. Additionally, many patients start ART late after the HIV disease is very advanced. This results in high death rates soon after starting ART. The factors that contribute to late ART initiation are still unclear. This study will identify factors that help patients to enroll or prevent them from enrolling into HIV care and starting ART on time. We will examine the characteristics of all patients initiating ART at study sites. We will also look at potential risk factors among patients who initiate ART late (cases) compared to patients who initiate earlier (controls) at 6 HIV care and treatment clinics in Ethiopia. Data will be collected using 2 methods: 1. Face-to-face interviews with participants using questionnaires 2. Obtaining clinical data from the electronic patient-level database Identifying factors that help patients to start or prevent them from starting ART on time will help to direct interventions, programs and policies to reduce early death.