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Virus Diseases clinical trials

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NCT ID: NCT00192478 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524

Start date: February 2004
Phase: Phase 1/Phase 2
Study type: Interventional

MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.

NCT ID: NCT00192465 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults

Start date: November 2003
Phase: Phase 1
Study type: Interventional

To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.

NCT ID: NCT00186927 Suspended - Parainfluenza Clinical Trials

A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers

Start date: May 5, 2005
Phase: Phase 1
Study type: Interventional

Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be admitted to the hospital and a few infants may require an intervention to help their breathing. This illness is most often caused by a virus called parainfluenza virus type 1, but it can be caused by other viruses. The experimental vaccine that is being investigated in this study is intended to try to prevent croup caused by parainfluenza virus type 1. Currently, there are no vaccines to prevent this virus, or medications available to treat the illness once infection has occurred. This research study is testing a new experimental live-virus vaccine that is given by placing liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup, but it has never been found to cause illness in people. Previous studies in animals have shown that the vaccine provided protection against the croup virus, and did not cause illness. Many people have been exposed to the Sendai virus, but no one has been known to develop illness. Several healthy adults have been given the Sendai virus vaccine being studied, and they did not experience any serious side effects or illness.

NCT ID: NCT00180674 Completed - Liver Fibrosis Clinical Trials

Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection

Start date: August 2005
Phase: Phase 2
Study type: Interventional

Patients who have been treated for hepatitis C virus (HCV) infection who have failed to respond to anti-viral treatment are often concerned about their ongoing liver disease and are therefore looking for alternative treatments which might prevent fibrosis progression. This view is endorsed by patient representative groups (including Charles Gore at the HepC Trust) who have welcomed this trial protocol. The study is a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2. Phase 1 (observation phase, 0 to 8 weeks) and Phase 2 (treatment phase with warfarin anticoagulation, 8 to 16 weeks). Study completed at end of Phase 2.

NCT ID: NCT00164073 Recruiting - Hepatitis C Clinical Trials

Pharmacogenomics of Interferon and Ribavirin Treatment in Patients With Chronic Hepatitis C Virus Infection

Start date: February 2004
Phase: N/A
Study type: Observational

The purpose of this study is to examine gene expression profiles by DNA microarray in patients who are responders and non-responders to interferon and ribavirin treatment for hepatitis C virus (HCV). Genes involved in inflammation and fibrosis and mediators of the Th-1 lymphocyte response will be looked for. It is hoped that genetic targets for future more effective and less toxic treatments will be identified.

NCT ID: NCT00164060 Terminated - HIV Infections Clinical Trials

Associations, Outcomes and Genomics of GB Virus C, Hepatitis C Virus and Human Immunodeficiency Virus Infection

Start date: February 2004
Phase: N/A
Study type: Observational

The purpose of this study is to examine the effect of GB virus C (GBV-C) on the natural history of chronic hepatitis C virus (HCV) infection in subjects co-infected with HIV and HCV. The other aspect of the study is to assess the effect of GBV-C on the severity of liver disease due to chronic hepatitis C in subjects co-infected with HIV and HCV. This will be done by determining the point prevalence of co-infection retrospectively then following that cohort prospectively. In addition, further individuals will be recruited in a prospective manner.

NCT ID: NCT00129766 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

Start date: November 2004
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

NCT ID: NCT00111878 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate MEDI-534 in Healthy Adults

Start date: April 2005
Phase: Phase 1
Study type: Observational

The primary objective of this study is to describe the safety and tolerability of a single dose of MEDI-534 when administered to healthy adult volunteers.

NCT ID: NCT00110279 Completed - Influenza Clinical Trials

Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study A)

Start date: June 2005
Phase: Phase 1
Study type: Interventional

Avian influenza (AI), or bird flu, has recently become a major health concern in Asia and other parts of the world. The purpose of this study is to test the safety of and immune response to a new AI vaccine in healthy adults. Study hypothesis: Influenza A viruses are widely distributed in nature and infect a wide variety of birds and mammals. The direct transmission of avian influenza viruses from birds to humans has recently become a major health concern in Asia and other parts of the world, raising concern of a possible influenza pandemic in humans. This vaccine will evaluate the safety, infectivity and immunogenicity of Live Influenza A vaccine H9N2 (6-2) AA ca reassortant (A/chicken/Hong Kong/G9/97 x A/Ann Arbor/6/60 ca), a cold-adapted, live attenuated virus vaccine administered intranasally for the protection of humans against pandemic influenza viruses of the H9N2 subtype.

NCT ID: NCT00070785 Completed - Clinical trials for Epstein-Barr Virus Infections

Protein Studies of the Epstein-Barr Virus in Ethnically Diverse Populations

Start date: October 6, 2003
Phase: N/A
Study type: Observational

This study will evaluate the ability of people of different ethnic backgrounds to develop immune responses against the Epstein-Barr virus (EBV). A common virus, EBV is present in 90 percent of healthy people and usually does not cause problems. Most people are infected in childhood, have no symptoms, and are unaware of their infection. People infected as adolescents or adults may develop infectious mononucleosis, which usually resolves completely. However, in immune suppressed people, like those who have had a transplant, EBV can cause fatal cancers. It can also cause certain cancers such as Burkitt's lymphoma, Hodgkin's lymphoma, and nasopharyngeal carcinoma in people who are not immune suppressed. Nasopharyngeal carcinoma is 100 times more common in people of Asian origin (particularly southern Chinese) compared with Caucasians. This difference may be the result of genetic, rather than environmental, factors. This study will examine whether the same proteins produced by EBV in the cancer cells react differently in people of different ethnic background in a way that could explain the differences in predisposition for this disease. Healthy normal volunteers 18 years of age and older of Caucasian or Chinese ancestry may be eligible for this study. Candidates of Chinese ancestry must be born in China (including Taiwan, Hong Kong, and Singapore, or be first generation offspring of parents born in these places). Participants will have a blood sample drawn and will undergo lymphapheresis - a procedure for collecting large numbers of white blood cells called lymphocytes. The blood sample is tested for blood counts and HLA type, a genetic marker of the immune system. HLA molecules help determine the way the body's immune cells respond to virus. HLA typing is similar to blood typing. Usually done to match stem cell or organ transplants, HLA testing may also be used to try to identify factors associated with an increased risk of certain diseases or conditions. HLA type is strongly associated with ethnic background. For lymphapheresis, blood is collected through a needle in an arm vein, similar to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm. The procedure takes 2 to 3 hours. The collected white cells are used for research for this study, including the ability to react to EBV proteins, and are then destroyed.