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Multicenter, open-label extension study to investigate the long-term safety and efficacy of IgPro20 in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in subjects completing study IgPro20_3003.

Primary objective: To evaluate the long-term safety of IgPro20.Secondary objectives: * To evaluate the long-term safety of IgPro20 by dose. * To evaluate the efficacy of IgPro20.Exploratory objectives:* To evaluate health-related quality of life (…

An open-label randomised two-year trial comparing two first-line regimens in HIV-infected antiretroviral naïve subjects:
darunavir/r + tenofovir/emtricitabine vs. darunavir/r + raltegravir

Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…

An open-label trial with TMC278 25 mg q.d. in combination with a
background regimen containing 2 nucleoside/nucleotide reverse
transcriptase inhibitors in HIV-1 infected subjects, who participated in
TMC278 clinical trials.

Primary ObjectiveThe primary objective of the trial is to provide continued access to TMC278 for subjects who were randomized andtreated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III trials (e.g., TMC278-TiDP6-C209[ECHO] and…

A multicentre, prospective, randomized open-label pilot study to assess the feasibility and preliminary efficacy of interferon gamma in combination with Anidulafungin for the treatment of candidemia

To evaluate the preliminary efficacy and feasibility of interferon gamma as adjunctive treatment in combination with the standard regimen, for the treatment of patients with candidemia using the following parametersSecondary objective: to evaluate…

The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial

OT population excludes patients lost to follow-up, or that discontinued DTG for reasons of intolerance or toxicity. ITT = all patients that took at least 1 DTG tabletPrimary objective:* To evaluate the efficacy of DTG monotherapy in maintaining…

A single dose study to evaluate the microdose pharmacokinetics of candidate HIV integrase
strand transfer inhibitors in healthy subjects

The purpose of the study is to investigate to what extent L-1, L-2 and L-3 are tolerated when administered as micro-dose.It will also be investigated how quickly and to what extent L-1, L-2 and L-3 are absorbed and eliminated from the body (this is…

A single-dose, open-label, randomized crossover study to assess the bioequivalence of darunavir 800 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg, in the presence of cobicistat 150 mg, administered as either a fixed-dose combination tablet or as separate agents in healthy subjects

The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…

Serum antibody response to influenza A in children with Down syndrome

Measuring specific antibody titers against influenza A (subtype H1N1 and / or seasonal vaccine) in DS children. DS anti-influenza antibody titers will be compared with controls available from the same laboratory.

A Randomized Open Label Study Comparing the Efficacy, Safety, and Tolerability of Oral Administration of Amantadine and Ribavirin with Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects

Primary: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy(i.e. amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivirmonotherapy in immunocompromised subjects diagnosed with Influenza…

A Phase I, open-label trial to investigate the pharmacokinetic interaction between TMC125 and two antifungal agents (fluconazole and voriconazole), all at steady-state in healthy subjects.

The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…

The role of TSH in the human immune system, a randomized, controlled, trial

The main objective of this study is to determine the role of TSH in the generation of new T cells by thymopoiesis

Genetics in Efavirenz Metabolism, the GEM study

To find an explanation for the abnormal blood levels of efavirenz. With the main research question: Are variations in genetic markers, e.g. CYP2B6 (subtype *6, *7 and *18), for the metabolism of efavirenz, an explanation for the abnormal…

The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)

In vitro data indicate that raltegravir is not a substrate of UGT1A4 or UGT2B7, but there is no evidence that raltegravir itself does not influence metabolism of other agents mediated by either UGT1A4 or UGT2B7.

A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

To characterize the profile of low BMD in >= 50 years old male HIV-1 infected subjects andpost-menopausal female HIV-1 infected subjects taking TDF-based regimens relative tothose taking non-TDF-based regimens for HIV infection.

A pilot study on the efficacy and pharmacokinetics of a switch from nevirapine with emtricitabine, tenofovir or lamivudine, tenofovir or lamivudine, zidovudine to rilpivirine with emtricitabine, tenofovir in virologically suppressed HIV-1 infected patients.

Primary objective:To evaluate the efficacy of a RPV based HAART in patients that switch from NVP with FTC, TDF or lamivudine (3TC), TDF or 3TC, zidovudine (ZDV) to RPV/FTC/TDF.Secondary objectives:To measure the impact (strength and duration) of NVP…

Efficacy of 12 week boceprevir in addition to standard of care therapy consisting of peginterferon-alpha-2b and ribavirin for the treatment of acute HCV genotype 1 in HIV co-infected patients. A proof of concept feasibility clinical trial.

Document the efficacy and tolerability of 12 weeks of Boceprevir (Victrelis®) therapy in addition to standard of care (SOC) therapy consisting of weekly weight based peginterferon alfa-2b (Pegintron®) SC and ribavirin PO BID, for the treatment of…

A randomized, multicenter study to assess the efficacy on disease activity on enteric-coated mycophenolate sodium (EC-MPS, myfortic) versus continuation of azathioprine in patients with systemic lupus erythematosus on azathioprine maintenance therapy.

To assess, in patients with systemic lupus erythematosus, the effect on disease activity of a regimen with myfortic® versus continuation of azathioprine.

Glivec (imatinib mesylate) in systemic sclerosis, a pilot study

To investigate the efficacy (and the toxicity) of Glivec in systemic sclerosis by examining clinical outcomes (clinical and laboratory findings).

A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the pharmacokinetic interaction between didanosine and TMC114, coadministered with low-dose ritonavir, at steady-state.

The primary objectives are:* to determine the effect of steady-state concentrations of TMC114 coadministered with a lowdose of ritonavir on the steady-state pharmacokinetics of ddI,* to determine the effect of steady-state concentrations of ddI on…

Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml

The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…