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Virus Diseases clinical trials

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NCT ID: NCT02337868 Completed - Clinical trials for West Nile Viral Infection

Phase 1 Trial of Inactivated West Nile Virus Vaccine

Start date: March 31, 2015
Phase: Phase 1
Study type: Interventional

This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation phase 1 trial, evaluating dosages of 1 mcg and 4 mcg of HydroVax-001 WNV vaccine given intramuscularly on Day 1 and Day 29 in up to 50 healthy adults > /=18 and < 50 years of age. The primary objective is to assess the safety, reactogenicity, and tolerability of the HydroVax-001 WNV vaccine administered intramuscularly in a two-dose series on Days 1 and 29 at a dose of 1 mcg or a dose of 4 mcg.

NCT ID: NCT02336139 Completed - Hepatitis C Clinical Trials

A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use

SIMPLIFY
Start date: March 16, 2016
Phase: Phase 2
Study type: Interventional

To evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following sofosbuvir/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug use.

NCT ID: NCT02335437 Completed - Clinical trials for Fatigue Syndrome, Chronic

Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

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

Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms. Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents undergoing acute EBV infection will be followed prospectively, and also compared with a group of healthy controls. The aim is twofold: - To identify factors that predispose to chronic fatigue among adolescents with acute EBV infection - To compare pathophysiological features of patients with acute EBV infection with a group of healthy controls. Possible risk factors for chronic fatigue 6 months after EBV-infection includes: - Severity of the initial infection - Immune responses characteristics - Characteristics of the neuroendocrine stress response - Cognitive functioning - Emotional disturbances - Genetics/ epigenetics of candidate genes - Certain personality traits - Critical life events

NCT ID: NCT02329054 Completed - Ebola Virus Disease Clinical Trials

Efficacy of Favipiravir Against Ebola (JIKI)

JIKI
Start date: December 2014
Phase: Phase 2
Study type: Interventional

There is no specific treatment for Ebola Virus Disease (EVD). Current EVD care are supportive, and includes intravenous or oral rehydration, nutrition, pain killers, treatment of coinfections with antibacterial and antimalarial drugs, and blood transfusion when appropriate. Despite these interventions, mortality remains high since the ongoing Ebola outbreak in West Africa was declared in April. Potential anti-Ebola specific interventions include convalescent plasma, monoclonal and polyclonal antibodies, small inhibitory RNA (siRNA), synthetic adenosine analogues or RNA polymerase inhibitors. All these interventions are considered investigational due to lack of data in humans with EVD. In this study, the investigators chose to study the efficacy of favipiravir because this drug: - showed anti-Ebola efficacy in immunodeficient murine models; - has been studied in thousands of adult humans participating in anti-influenza trials, with good tolerance; it has been approved for treating novel or resistant influenza infections in Japan; - is immediately available; - can be used orally, and can be easily given in both adults and children because pills can be crushed and mixed in food or liquids; - has recently been used in Europe for treating several patients with EVD; the French drug safety agency (ANSM) has reviewed published data as well as data provided by the firm (Toyama Chemical Co., Ltd), and approved its compassionate use in EVD. Here the investigators propose to assess the efficacy of high-dosed favipiravir in reducing mortality in humans with EVD. In the present trial "JIKI" (means "Hope" in "Kissi" language), investigators, sponsor, scientific advisory board and safety monitoring board will be coordinated in a very reactive way, so that any new fact can be discussed rapidly and the research plan can be adapted accordingly (change in drug dosage; use of drug combination; combination with another strategy such as passive immunization with convalescent plasma, etc.).

NCT ID: NCT02326194 Completed - Ebola Virus Disease Clinical Trials

A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.

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

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃. This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.

NCT ID: NCT02325791 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants

Start date: July 21, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age at the time of enrollment in their respective geographic location. In order to optimize the potential benefit in this vulnerable population, we conducted this study during the RSV season using dosing regimens that are expected to be effective.

NCT ID: NCT02319772 Completed - Clinical trials for Ebola Virus Infection

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430

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

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days.

NCT ID: NCT02316938 Completed - Kidney Failure Clinical Trials

Assessing DSA Formation, Diabetes, Viral Infections, Structural Kidney Changes With an Everolimus-based Regimen (ADVISE)

ADVISE
Start date: February 22, 2015
Phase: Phase 4
Study type: Interventional

CRAD001AAU13 is a substudy of CRAD001A2433. The core study CRAD001A2433 is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating graft function with everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients. Patients in this study may use cyclosporine or tacrolimus as the CNI.

NCT ID: NCT02311387 Completed - Clinical trials for Lassa Virus Infection

Seroprevalence and Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali

Start date: December 5, 2014
Phase:
Study type: Observational

Background: - Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and droppings. When a group of researchers tested the mice in Soromba, Mali, they found that many were infected with Lassa fever. Lassa fever may also be passed through body fluids (like blood or semen) of people infected with Lassa fever. Researchers want to study this disease to help the government better protect the health of people in Sibirila. Objectives: - To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how many people get the disease every year. Eligibility: - People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no plans to relocate within 1 year. Design: - Households will be randomly selected to participate in the study. - Participants will have up to 20 drops of blood collected from the finger or heel. - Participants will be asked about their age. They will be asked if they have ever had a fever and if they have ever seen mice in or around their home. - Researchers will come back in 1 year and take another drop of blood from the participant. Participants will be asked the same questions. - If a participant has a fever at any time during the year, he or she should go to the health center. Researchers will collect a few drops of blood to test for Lassa fever. ...

NCT ID: NCT02309918 Completed - Acute Hepatitis C Clinical Trials

HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection

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

This is an open-label, single arm, multicenter, pilot-study to compare the efficacy and safety of LDV/SOF fixed dose combination (FDC) in subjects with acute genotype 1 HCV infection. A total of 20 subjects will be assigned to receive LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg/) once daily for 6 weeks.Patients will be followed up for 24 weeks.