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Virus Diseases clinical trials

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NCT ID: NCT02469298 Completed - Virus Diseases Clinical Trials

Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza

Start date: June 1, 2015
Phase: Phase 2
Study type: Interventional

Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits neutrophil transmigration and activation to areas of inflammation. The study endpoints are intended to test the hypothesis that inhibition of neutrophil activation by approximately 50-60% (as previously measured by cluster of differentiation [CD11b] expression in response to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not impact safety parameters or worsen clinical manifestations of disease, disease-related events of interest, or viral load, and may possibly improve these parameters when administered within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX]) alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated influenza prior to future evaluation in hospitalized patients with complicated influenza. The primary objective is to assess safety and tolerability of DNX with and without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an assessment of disease related events (DREs) of interest and associated antibiotic use. The Influenza Intensity and Impact Questionnaire (FluiiQâ„¢) will be used in the study to document patient reported outcomes (PROs). The screening visit in Australia will be composed of a pre-screen for influenza infection with an influenza rapid antigen test followed by a screen for the remaining eligibility criteria for those subjects with a positive result on the influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health Private Limited.

NCT ID: NCT02465190 Not yet recruiting - Clinical trials for Influenza Viral Infections

Effectiveness of Trivalent Inactivated Influenza Maternal Vaccination Among Pregnant Women and Their Newborns in South Africa

Start date: June 2015
Phase: N/A
Study type: Observational [Patient Registry]

This is a case-control study embedded in a surveillance system to determine the effectiveness of antenatal maternal influenza vaccination against laboratory-confirmed influenza-associated hospitalised illness in infants <6 months of age.

NCT ID: NCT02461563 Completed - Clinical trials for Hepatitis C Virus Infection

A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)

Start date: June 23, 2015
Phase: Phase 1
Study type: Interventional

This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.

NCT ID: NCT02460016 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Study of AK0529 in Infants Hospitalized With RSV

Start date: August 28, 2015
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).

NCT ID: NCT02456610 Recruiting - Viral Infection Clinical Trials

Administration of Virus Specific CTLs for the Prophylaxis and Treatment of EBV/CMV Infections After HSCT in China

Start date: May 2015
Phase: Phase 1
Study type: Interventional

Cytomegalovirus (CMV) and Epstein Barr Virus (EBV) cause significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients in China. Antiviral drugs given either prophylactically or as early therapy for patients with detectable viral loads appear to be an effective strategy for reducing viral infections. However, long-term treatment with these drugs is associated with significant toxicity, expense and the appearance of drug resistant virus isolates ultimately resulting in treatment failure. CMV and EBV specific T cells infusion to immunocompromised patients following HSCT is able to induce a successful anti-viral response. The primary purpose of this study is to determine the safety and efficacy of the infusion of CMV and EBV specific cytotoxic T cells (CTLs) for patients with CMV and EBV reactivation or infection.

NCT ID: NCT02452242 Completed - Clinical trials for Human Immunodeficiency Virus Infections

Safety, PK and PD Study of ABX464 in Untreated HIV Patients

Start date: January 2015
Phase: Phase 2
Study type: Interventional

ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV. Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.

NCT ID: NCT02452229 Completed - Burns Clinical Trials

Review of Human Herpes Viruses in Burns

Start date: March 2015
Phase: N/A
Study type: Observational

Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing systematic review (Level of Evidence III or higher) describing the unique role as well as concurrent infections of these viruses in burns. The aim of this review is to point out the clinical differences between these human herpes virus subtypes, to outline established therapy approaches, and to provide evidence for virus related morbidity and mortality in burns.

NCT ID: NCT02451891 Active, not recruiting - Ebola Virus Disease Clinical Trials

A Phase I Study to Assess Ebola Vaccines cAd3-EBO Z and MVA-EBO Z

Start date: April 2015
Phase: Phase 1
Study type: Interventional

This is a clinical trial in which healthy volunteers will be administered experimental Ebola vaccines. The investigators will vaccinate four groups of volunteers. Group one will receive the MVA-EBO Z vaccine once at the dose of 1 x 10^8 pfu. Three groups will receive the prime vaccine cAd3-EBO Z followed by the boost vaccine, MVA EBO Z. The second group of volunteers will receive the boost vaccine after 14 +/-7 days at a dose of 1 x 10^8 pfu and the third and fourth group, after 28 +/- 7 days but at different concentrations of MVA-EBO Z (1 x 10^8 pfu for group 3 and 1.5 x 10^8 pfu for group 4). The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples. The cAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it. Healthy volunteers will be recruited in Oxford and London England. The study will be funded by the Wellcome Trust.

NCT ID: NCT02447705 Completed - Virus Diseases Clinical Trials

Replacement of Lamivudine by Telbivudine to Improve Renal Function

Start date: June 2013
Phase: Phase 2/Phase 3
Study type: Interventional

Nephrotoxicity is one of the adverse effects of lamivudine and dosage of lamivudine has to be reduced if patients' renal function is insufficiency. Telbivudine may improve glomerular filtration rate. This study is to see whether renal function is improved when Lamivudine is replaced by telbivudine in liver transplantation patients.

NCT ID: NCT02431923 Completed - Ebola Virus Disease Clinical Trials

Ebola Virus Disease Survivors: Clinical and Immunologic Follow-up

Start date: December 2, 2017
Phase:
Study type: Observational

Background: - Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects. Researchers want to learn what ill health conditions Ebola survivors have. They want to learn if Ebola survivors can infect others in their household through close contact. They also want to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they want to follow people in Liberia for 5 years. Objectives: - To learn how Ebola affects the health of survivors and the people they live with. Eligibility: - People in Liberia who had Ebola in the past 2 years, who share a household with someone who had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because they did not have Ebola. Design: - Participants will be screened with family illness history, physical exam, and blood tests. They may have an eye exam. - Ebola survivors and those who went to a Treatment Unit but did not have Ebola will visit a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit, they will repeat the screening tests. - Participants who live with someone who had Ebola will have only the screening visit. But they may be asked to return for follow-up visits. These visits will help researchers learn more about the differences between those who have had Ebola and those who have not. - Participants brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and a clinical syndrome compatible with acute EVD. - The study will last 5 years.