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Hepatitis B clinical trials

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NCT ID: NCT01125696 Completed - HIV Clinical Trials

Safety Study of a Tenofovir-containing Drug Regimen for the Prevention of Mother-to-child Transmission of HIV and HBV

TiP
Start date: May 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO-recommended and locally practiced standard of care regimen consisting of zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test regimen in pregnant women and their newborns. While the study is not powered to examine efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate of resistance development will be obtained.

NCT ID: NCT01124591 Completed - HIV Infections Clinical Trials

Brief Intervention for Drug Misuse in the Emergency Department

BIDMED
Start date: June 2010
Phase: Phase 2
Study type: Interventional

Although screening, brief intervention, and referral to treatment (SBIRT) approaches are effective in reducing alcohol misuse and its associated risk-taking behaviors and negative consequences, there is little research demonstrating the effectiveness of SBIRT for illicit and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently seek medical care in emergency departments (EDs), particularly for reasons related to their misuse. As a result, the ED is well suited as a site to conduct an analysis of the effectiveness of SBIRT for this population. The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a randomized, controlled, trial that will include adult ED patients at a large, academic, trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have a subcritical illness or injury and whose screening indicates illicit and/or prescription drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief intervention (BI) with appropriate referral to treatment. Participants will complete a battery of blinded baseline assessments using standardized instruments as well as adapted instruments specific to the aims of this study. All participants will undergo blinded follow-up assessments at three, six, and twelve months post-randomization. The primary hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm, participants in the BI arm will show a significantly greater reduction in: (1) drug misuse within the prior 30 days at three months post-randomization, (2) behaviors associated with drug misuse at six months post-randomization; and (3) negative physical health, psychosocial health, and socioeconomic consequences at twelve months post-randomization. As a secondary aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling in, and completing a drug treatment program. In addition, the impact of BI compared to SO on increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change model that addresses the expected mediators and moderators of change to explain the effects of SBIRT in this setting will also be developed and tested. Further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.

NCT ID: NCT01107483 Completed - Clinical trials for Hepatitis B, Chronic

Observe Change of Endotoxaemia and Related Mediators in Patients With Chronic Hepatitis B Virus (HBV) Infection

OCEHBV
Start date: December 2009
Phase: N/A
Study type: Observational

This study was designed for changes in endotoxaemia, endotoxin-binding factors, sICAM-1 (soluble intracellular adhesion molecule-1), and cytokines during progression of chronic HBV infection. Patients with chronic HBV infection and healthy control are included. A limulus assay was used to measure plasma endotoxin level and ELISAs were used to measure the concentrations of interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor-α (TNFα), sICAM-1, and soluble CD14 (sCD14).

NCT ID: NCT01106092 Completed - Hepatitis B Clinical Trials

Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

Start date: May 13, 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

NCT ID: NCT01105559 Completed - Hepatitis B Clinical Trials

Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine

Start date: April 2010
Phase: Phase 3
Study type: Observational

The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336). Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months

NCT ID: NCT01102335 Recruiting - Clinical trials for Hepatocellular Carcinoma

Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy

TACEHBV
Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.

NCT ID: NCT01098006 Completed - Immunologic Tests Clinical Trials

A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays

Start date: April 29, 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and characterize immunological assays on blood samples.

NCT ID: NCT01095835 Completed - Clinical trials for Hepatitis B, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

Start date: February 2005
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy and safety of 2 different durations of treatment with PEGASYS, in patients with HBeAg-negative chronic HBV. It will also compare PEGASYS treatment alone and in combination with lamivudine. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

NCT ID: NCT01090531 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy

Start date: August 2009
Phase:
Study type: Observational

This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is <1000.

NCT ID: NCT01090453 Completed - Hepatitis B Clinical Trials

Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

Start date: May 17, 2010
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.