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Virus Diseases clinical trials

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NCT ID: NCT01490359 Completed - Clinical trials for Sexually Transmitted Diseases

Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men

Start date: November 2007
Phase: N/A
Study type: Interventional

Sub-Saharan Africa has about 10% of the world's population, but was home to more than 60% of all people living with HIV in 2003. South Africa continues to have the largest number of people living with HIV in the world, and as in other parts of sub-Saharan Africa, heterosexual exposure is the primary HIV transmission category. Worldwide, efforts to stem the spread of HIV among heterosexuals have stressed the impact of HIV on women. Oft-cited statistics indicate that about half of all people living with HIV are women. The strategies typically offered to address the impact of HIV on women are interventions with women. An alternative approach to addressing women's risk of heterosexual transmission of HIV, one that would be an important complement to the predominant approach, is focusing on men. By reducing sexual risk behavior of men, it should be possible to reduce rates of HIV in both men and women. The rates in men would decline because they are the recipients of the intervention; rates in women would decline because they have sex with men. Interventions aimed at men could take into account the power that men have in sexual decision-making and risk taking. However, whether one considers the US literature or the international literature, few randomized controlled trials of HIV/STD risk-reduction interventions have focused on heterosexual men. Accordingly, the purpose of this research is to develop and test the efficacy of an intervention to curb HIV/STD risk-associated behavior in South African men who have sex with women. A cluster-randomized controlled trial design will be used to reduce the potential for contamination between treatment arms that would be present if individuals were randomized. An attention control group will be used to control for Hawthorne effects, special attention, and group interaction. Matched pairs of neighborhoods in Black townships in Eastern Cape Province, South Africa similar on key characteristics will be created, 22 pairs will be randomly selected, and men will be recruited. One neighborhood in each pair will be randomly assigned to each of the 2 study arms. We hypothesized that men who receive a culturally appropriate theory-based HIV/STD risk-reduction intervention will be more likely to report consistently using condoms during intercourse in the 12-month post intervention period than will men who receive an attention-control intervention, adjusting for baseline condom use.

NCT ID: NCT01489358 Completed - Chikungunya Fever Clinical Trials

Chikungunya Virus Vaccine Trial in Healthy Adults

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

Background: - Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death. But the joint pain, which may be directly related to the infecting virus, may be severe and last for several months. CHIKV outbreaks are most common in Africa, India, and Asia. A new experimental vaccine for CHIKV has been developed, and researchers are testing it in healthy adults. Participants cannot develop CHIKV from this vaccine. Objectives: - To test the safety and effectiveness of a Chikungunya virus vaccine. Eligibility: - Healthy individuals between 18 and 50 years of age. Design: - This study, including vaccine doses and followup tests, will last about 44 weeks. Participants will have three vaccination visits, six followup clinic visits, and three telephone contacts during this study. Vaccination visits will take about 4 hours. Most other clinic visits will usually take 2 hours. The telephone contacts will take about 15 minutes. - Participants will be screened with a physical exam and medical history. Blood samples will also be collected. - Participants will be assigned to one of three dose groups. Information about doses will be provided before the start of the vaccinations. - Vaccine injections will be given at the start of the study, at 4 weeks, and at 20 weeks. Participants will be asked to keep an eye on the injection site for 7 days and to notify researchers if there are any side effects. - Participants will be monitored throughout the study with blood samples and clinic visits.

NCT ID: NCT01486160 Completed - Clinical trials for Acute Viral Respiratory Tract Diseases

Respiratory Viral Infection in Nursing Home Slovenia

Start date: December 2011
Phase: N/A
Study type: Observational

This study will be conducted in a 208-bed nursing home in Maribor. The investigators will observe a group of a 100 nursing-home residents and 50 health care workers- employees in the nursing home- in a six months period.Influenza vaccination status will be recorded in all participants at the beginning. At the beginning and at the end of the study the blood samples for vitamin D concentration determination and nasopharyngeal swabs for molecular detection of respiratory viruses will taken in all of the participants. The study will observe number of viral respiratory tract infection in participants and identify the viral etiology of infections during 6 months observational period.Nasopharyngeal swab and blood sample will be taken in each of the participant who will suffer an acute respiratory tract infection (upper or lower respiratory tract infection) and viral agents of respiratory tract diseases will be searched for. The investigators will try to detect different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses, influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in nasopharyngeal swab and in blood sample of the participants. During the study period the investigators will monitor the daily number of visitors (adults, preschool children and pupils) in each nursing home room. The epidemiological aspect of respiratory viral infection will be assessed. Our study hypothesis is that lower respiratory tract infections in elderly can be caused by viruses other than influenza. The investigators would like to know if hypovitaminosis D is a risk factor for respiratory tract infections in nursing home residents and employees. The investigators would also like to know if the number of respiratory tract infections in elderly correlates with the number of visitors in nursing home, small children in particular.

NCT ID: NCT01482611 Completed - Clinical trials for Hepatitis C Virus Infection

A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382

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

The purpose of this study is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up to the maximum tolerated dose or up to the dose that yields a JNJ-47910382 plasma level that approaches the predefined maximum mean exposure (whichever comes first) in healthy Caucasian and Japanese participants. The foreseen maximum dose is 600 mg. In addition, the effect of fasting (ie JNJ-47910382 is taken without food) on the plasma pharmacokinetics of JNJ-47910382 after one selected oral dose given to healthy Caucasian participants will be studied. JNJ-47910382 is a drug that is being developed to treat Hepatitis C infection and is an inhibitor of the reproduction machinery of the Hepatitis C virus (HCV). Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

NCT ID: NCT01480258 Completed - Clinical trials for Bacterial Infections

Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)

Start date: November 23, 2011
Phase: Phase 3
Study type: Interventional

This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I.

NCT ID: NCT01473056 Completed - Clinical trials for Hepatitis C Virus Infection, Response to Therapy of

Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects

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

The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.

NCT ID: NCT01466062 Completed - Clinical trials for Respiratory Syncytial Virus Infection

Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

Start date: August 2011
Phase: Phase 3
Study type: Interventional

To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

NCT ID: NCT01459198 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Evaluating the Safety and Immune Response to a Respiratory Syncytial Virus (RSV) Vaccine in Adults, RSV-Seropositive Children, and RSV-Seronegative Infants and Children

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

Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and pneumonia. RSV affects almost all children within the first 2 years of life. This study will evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults, RSV-seropositive children, and RSV-seronegative infants and children.

NCT ID: NCT01459081 Completed - Clinical trials for Influenza A Virus Infection

Efficacy and Safety of Inhaled Zanamivir in Treatment of Influenza A and B Virus Infections in China

Start date: October 2011
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the clinical efficacy and safety of inhaled zanamivir in treatment of influenza A and B virus infections in China.

NCT ID: NCT01447680 Completed - Hepatitis C Clinical Trials

Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing

Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of this study is to compare the results for HIV and/or Hepatitis C Virus antibody testing when using routine plasma versus SMARTplasma from the same blood sample. SMARTplasma is enriched for antibodies via a stimulation step of whole blood in a SMARTube™ (SMARTstim™ in the USA).