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Maraviroc Immune Recovery Study (MIRS):
A multicentre, randomized, placebo-controlled, exploratory mechanistic study into the role of Maraviroc on immune recovery

The primary objective is to confirm the hypothesis that Maraviroc stimulates immune recovery; the ssecondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.

Lowering viral load with nucleos(t)ide analogues prior to peg-interferon alfa-2b treatment to increase sustained response in HBeAg-positive chronic hepatitis B (PADD-study)

To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral loadDetermine the effect of PEG-IFNa on NK cell function and…

Eurosupport 6: Testing the effectiveness of a computer-assisted counselling intervention on safer sex (CISS) for people living with HIV (PLHIV)

- To develop evidence-based and theory-guided target group specific interventions to improve the SRH of two specific groups of PLHIV, MSM and migrants, with particular emphasis on reduction of HIV transmission behaviour.- To test the effectiveness…

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects (Part A), and in Chronic Hepatitis C Genotype 1 Infected Patients (Part B).

Primary1. To evaluate the safety, tolerability and pharmacokineticproperties of RO5428029 in healthy subjects and chronichepatitis C genotype 1 infected patients.2. To evaluate pharmacodynamics (viral load response) ofRO5428029 in chronic hepatitis…

A phase 3, randomized, double-blind study to evaluate the safety and efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 versus Ritonavir-Boosted Atazanavir plus Emitricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naive adults.

The primary objective of this study is:To evaluate the efficacy of a regimen containing elvitegravir/emtricitabine/tenofovir disoproxil fumarate/GS 9350 versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV 1…

A Phase 3 Study with Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects with Chronic Hepatitis C Genotype 1b Infection.;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 13-Mar-12)

Primary Objective:This research study is designed to assess the effectiveness of the combination of study drugs (ASV + DCV) being used to treat the hepatitis C virus (HCV). The best way to assess this aim is to measure the amount of virus in…

LOWERING VIRAL LOAD WITH NUCLEOS(T)IDE ANALOGUES PRIOR TO PEGINTERFERON ALFA-2B TREATMENT TO INCREASE SUSTAINED RESPONSE IN HBEAG-POSITIVE CHRONIC HEPATITIS B (PEGON-STUDY)

To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis Bpatients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…

Phase I, single-centre, randomised, placebo-controlled, double-blinded study, with single ascending dose and multiple dose at maximum tolerated dose, evaluating the safety, tolerability and pharmacokinetics of ALX-0171, administered by pulmonary inhalation, in healthy male volunteers

- to determine the safety and tolerability of escalating single doses and multiple doses of ALX-0171- to evaluate the dose-limiting toxicity (DLT) level of ALX-0171 and determine the maximum tolerated dose (MTD)- to evaluate the PK of escalating…

High-dose versus standard-dose weight-based ribavirin in combination with peginterferon alfa-2a for patients infected with hepatitis C virus genotype 1 or 4

To investigate if high-dose ribavirin in combination with peginterferon alfa-2a can improve outcome in treatment naïve hepatitis C patients with genotype 1 or 4 and a high viral load (>400.000 IU/ml).

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients with Chronic Genotype 2 or 3 HCV Infection

Primary:* To determine the efficacy of PSI-7977 in combination with RBV administered for 12 weeks compared with PEG/RBV administered for 24 weeks in treatment-naïve patients with HCV genotype 2 or 3 as assessed by the rate of SVR12 (HCV RNA of…

NAI114373: A Phase III international, randomized, doubleblind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza (NAI114373)

Primary: To assess the efficacy of treatment with 300 mg or 600 mg of intravenous (IV) zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily on time to clinical response. Secondary: reduction in viral load from nasopharyngeal swabs…

eMate - Intelligent online monitoring and support for chronic patients

Patients with chronic diseases require long-term adherence. Adherence can be improved by patient counseling as is common in disease management programs. However, personal counseling is expensive, especially given the fact that chronic patients will…

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, with and without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination with Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 30-Mar12)

Primary Objective:The primary objective for this study is to evaluate, in treatment-naive subjects with chronic HCV GT-2 or -3 infection:* SVR12 following 24 weeks of treatment with Lambda/RBV and the SVR12 following 24 weeks of treatment with alfa-…

A phase 3, randomized, double-blind study to evaluate the safety and efficacy of GS-9350-boosted Atazanavir versus Ritonavir-boosted Atazanavir each administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naive adults.

The primary objective of this study is:To evaluate the efficacy of a regimen containing GS 9350-boosted Atazanavir versus ritonavir-boosted atazanavir each administered with emtricitabine/tenofovir disoproxil fumarate in HIV 1 infected,…

A Phase 3, randomized, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects (ING114467)

Primary: Antiviral efficacy of dolutagravir in combination with Kivexa (abacavir en lamivudine) after 48 weeks of treatment in comparison with Atripla (tenofovir, emtricitabine and efavirenz). Secondary: Antiviral efficacy after 96 and 144 weeks,…

Phase I clinical trial to assess safety and immunogenicity of an MVA-based influenza H5 vaccine in healthy adults

Primary objectiveSafety assessment of the MVA-H5-sfMR vaccine in humans. Study subjects will undergo physical examinations performed before and on fixed time points during the study. Clinical chemistry is performed on the blood samples that are…

A Phase 3, Randomized, Double-Blind Study to Evaluate the
Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/
Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/
Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1
Positive, Antiretroviral Treatment- Naïve Adults

The primary objective of this study is:• To evaluate the efficacy of a single-tablet regimen (STR) containingelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STRcontaining elvitegravir/cobicistat/emtricitabine/…

Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients with Chronic Hepatitis B Virus Infection who are HBeAg-positive

Primary objectives:• To evaluate the safety and tolerability of BMS-914143 as measured by the frequency of SAEs and discontinuations due to AEs;• To assess the HBeAg seroconversion rate at 24 weeks off treatment (Week 72).Secondary objective• To…

Immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial parvovirus B19 persistence - a prospective, double-blind, randomized, placebo-controlled clinical trial

A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac…