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Virus Diseases clinical trials

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NCT ID: NCT01112033 Completed - Clinical trials for Hepatitis C, Chronic

Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Start date: June 2010
Phase: N/A
Study type: Observational

In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects.

NCT ID: NCT01107535 Completed - Clinical trials for Respiratory Syncytial Virus Infection

Effectiveness of Synagis (Palivizumab) Immunoprophylaxis in Preterm Infants With High Risk of Severe Respiratory Syncytial Virus (RSV) Infection

INSPIRA
Start date: September 2007
Phase: N/A
Study type: Observational

Published data by the Organización panamericana de la Salud shows that Peru's mortality rate from acute respiratory infections (ARI) in infants less than one year of life is second only to Haiti (14,150/100,000). Government data reports shows a marked increase of RSV infections in Peru. "Instituto Nacional de Salud" (Peru's National Institute of Health) reports between January 1st to February 26th 2006, 62% of their positive samples corresponded to RSV. Epidemiological data from Lima-Peru, demonstrates that there is no specific season for RSV infection although some data suggest an increase in RSV activity during cold months (May to September; INS data). Clinical studies show that giving five doses of Synagis (palivizumab) resulted in serum concentrations > 30 ug/mL for >20 weeks. The aim of this post-marketing observational study is to determine the RSV hospitalization rate in high-risk infants who received Synagis (palivizumab) through the Social Security Hospitals in the context of routine clinical practice.

NCT ID: NCT01107262 Completed - Virus Diseases Clinical Trials

Avian Influenza Studies In Lebanon

Start date: July 2009
Phase: N/A
Study type: Observational

The highly pathogenic avian influenza (HPAI) H5N1 virus arrived in the Middle East in 2005 and has since established itself in local domestic birds and is now considered endemic in several Middle Eastern countries.Few studies indicate the presence of low pathogenicity avian influenza (LPAI) viruses of the H9 type among Lebanese poultry and wild birds. These studies also provide some evidence suggesting that humans exposed to these sick birds are showing elevated antibody titers against these LPAI H9 viruses. This study will focus on the following objectives: - To determine the seroprevalence of AI in poultry-exposed and non-exposed human populations. - To identify risk factors associated with AI infections in occupationally-exposed poultry workers. - To conduct nation-wide cross-sectional surveillance for AI viruses among domestic birds in low biosecurity farms and backyard flocks.

NCT ID: NCT01097395 Completed - Hepatitis C Virus Clinical Trials

Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection

Start date: February 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease will be randomized to receive concentration-guided or standard weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided through the study.

NCT ID: NCT01096576 Completed - Dengue Clinical Trials

A Study of Balapiravir in Patients With Dengue Virus Infection

Start date: July 2010
Phase: Phase 1
Study type: Interventional

This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200

NCT ID: NCT01090232 Completed - Clinical trials for Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Host Responses in Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection

Start date: February 2010
Phase: N/A
Study type: Interventional

Hepatitis E is a worldwide disease. It is the leading or second leading cause of acute hepatitis in adults in developing countries from sub-Saharan Africa or Southeast Asia, where it is hyperendemic and principally water-borne. In industrialised western countries, hepatitis E was until recently considered as imported from hyperendemic geographical areas, but is currently an emerging autochthonous infectious disease. A growing body of data from Europe, America, Australia, and Asia strongly indicate that pigs represent a major Hepatitis E Virus (HEV) reservoir and might be a source of zoonotic transmission to humans through direct or indirect exposure. Hepatitis E typically causes self-limited acute infection. However, the overall death rate is 1-4%, and it can reach 20% in pregnant women and might be still higher in patients with underlying chronic liver disease. To date, no preventive or curative treatment of hepatitis E is available.

NCT ID: NCT01075178 Completed - Clinical trials for Severe Respiratory Syncytial Virus Infection

Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease

Start date: July 2006
Phase: N/A
Study type: Observational

Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

NCT ID: NCT01072695 Completed - HCV Infection Clinical Trials

Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus Infection

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This a phase 2, randomized, open-label trial of GS-9256 plus GS-9190, two oral anti HCV drugs, for 28 days with and without ribavirin (RIBA) and with pegylated interferon (PEG)/RIBA in adults with chronic Hepatitis C virus (HCV). In Part A, approximately thirty (30) subjects 18-70 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of the two treatment groups (GS-9256 plus GS-9190 or GS-9256 plus GS-9190 plus RIBA). In Part B, an additional fifteen (15) subjects will receive 75 mg GS-9256 BID plus 40 mg GS-9190 BID in combination with PEG/RIBA. After the 28-day treatment period, subjects will receive PEG/RIBA as standard of care (SOC). Following randomization, subjects will return for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 28 day treatment phase. During the treatment phase, subjects will receive oral study drugs twice daily for 28 days and PEG once weekly for Part B. Subjects then receive PEG/RIBA as local SOC starting on Day 28 (not provided as part of the study). Following completion of the 28-day treatment phase, subjects will be followed for approximately 72 weeks.

NCT ID: NCT01070797 Completed - Clinical trials for Cytomegalovirus Infections

Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE)

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

Patient's on this protocol have a type of blood cell cancer, other blood disease or a genetic disease and have received a stem cell transplant. The donor of the stem cells was either a brother or sister, another relative, or a closely matched unrelated donor. The patient is being asked to participate in this study which tests if blood cells from the donor that have been grown in a special way, can prevent or be an effective treatment for early infection by three viruses - Epstein Barr virus (EBV), cytomegalovirus (CMV) and adenovirus. Adenovirus is a virus that usually causes symptoms of a common cold, but can cause serious life-threatening infections in patients who have weak immune systems. It can affect the lungs and cause very serious pneumonia, and can also damage the gut, liver, pancreas and eyes.CMV can also cause serious infections in patients with weak or suppressed immune systems. It usually affects the lungs, causing a very serious pneumonia, but it can also affect the gut, the liver and the eyes. Approximately 2/3 of normal people harbor this virus in their body. In healthy people CMV rarely causes any problems because the immune system can keep it under control, but after a transplant, the risk of developing CMV disease is much higher because the immune system is so weak. EBV is the virus that causes glandular fever. It is also a life long infection like CMV that is normally controlled by the immune system. When immunity is weak, the virus can become active and cause fevers, enlarged lymph nodes and sometimes a type of cancer called lymphoma. Investigators want to see if a kind of white blood cell called T lymphocytes (T cells)can be used to prevent and treat adenovirus, CMV and EBV in the early stages of reactivation or infection. T cells have been grown from the patient's stem cell donor in the laboratory in a way that will train them to recognize the virus and control it when they are given after a transplant. This treatment with specially trained T cells (also called CTLs) has had activity against these viruses in previous studies and in this study investigators want to see if they still have activity when they are made in a simpler and faster way. These donor-derived multivirus-specific special cell lines are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to evaluate whether donor-derived multivirus-specific special cell lines are safe and can control three viruses: EBV, CMV and adenovirus.

NCT ID: NCT01065935 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

Start date: February 2010
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients