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Investigation of gene variants associated with resistance and susceptibility to HIV-1 infection in HIV-1 exposed but uninfected individuals with haemophilia A.

To identify human genetic variants that influence susceptibility or resistance to HIV infection

A two-period microdosing study to determine the single-dose pharmacokinetics of ITMN-8187 after intravenous and oral administration in healthy subjects.

Primary:- to determine the pharmacokinetics (PK) of parent drug and total radioactivity after administration of the studydrugSecondary:- to determine the absolute bioavailability of ITMN-8187 after oral administration- to investigate the safety and…

Immunity after yellow fever vaccination in travelers using immunosuppressive medication-YETI study

To compare: - the rate of local and systemic adverse events- height and duration of antibody presence using the plaque reduction neutralization test; - The number of yellow fever specific CD8+ T cells in peripheral blood mononuclear cells (PBMCs);…

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…

Response to vaccination in lymphoma patients treated with CHOP and rituximab.

To investigate what the ideal moment to vaccinate would be, early (after 2-6 months) or late (after 9-12 months) after cessation of rituximab. Secondly to study the immune-response to vaccination with influenza virus vaccine after treatment with…

Immunological monitoring of VZV vaccination in patients with renal failure versus healthy individuals

To study if there is a role for prophylactic VZV vaccination prior to transplantation to boost the patients B- and T-cell repertoire and thereby reducing the incidence and morbidity associated with herpes zoster.

Pharmacokinetic Interaction between Antiretroviral and Cytotoxic therapy in HIV-infected patients - a pilot study

1º Is there a significant difference of more than 10% in the pharmacokinetic parameter AUC of the investigated antineoplastic drugs (as a surrogate parameter for the efficacy) in the presence and absence of NNRTIs and/or PIs?2º Are there clinically…

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…

Neurological, visual and neurocognitive performance in pediatric HIV-1- infected patients as compared to healthy controls.

To evaluate neurologic- and cognitive disorders, neuroimaging and ophthalmological alterations in perinatally HIV-infected children in comparison to matched (with respect to age, sex, race, home environment and socio-economic status) healthy…

The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX)

Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…

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…

Pharmacokinetic drug interaction study between rAltegraVIr and ATORvastatin (AVIATOR).

Primary objective:To assess the effect of multiple dose atorvastatin on the steady state pharmacokinetics of raltegravir and vice versa by intrasubject comparison in healthy subjects.• The comparison of steady state raltegravir (400 mg BID for 7…

Feasibility of Diffusion Tensor Imaging MRI in post-polio syndrome

The main objective of this study is to compare DTI findings of PPS patients with those of healthy controls. Secondary objective of this study is to correlate DTI findings with clinical data such as isometric muscle strength. Third objective is to…

T cell-mediated immunity targeting polyomavirus BK

Clarifying the qualitative and quantitative aspects of the T cell response targeting and controlling polyomavirus BKV.

The pathogenesis of dengue virus infection in patients with sickle cell disease

To elucidate the pathogenetic mechanism of endothelial cell activation in DENV infected patients with sickle cell disorder.

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…