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Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients

MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…

A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.

Randomized, multicenter, double-blind, placebo-controlled, parallel group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

The primary objective of the study is to determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placeboSecondary objectives:* To investigate the efficacy of…

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…

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…

Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911.

Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…

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…

Phase I, double-blind, randomized, placebo-controlled trial in healthy volunteers to examine the safety, tolerability and plasma pharmacokinetics of TMC589337 and TMC589354 after increasing single oral doses and in an open-label part after different repeated oral doses in combination with a single oral dose of TMC310911.

To investigate the safety, tolerability and behavior in the body (absorption and excretion) of oral intake of TMC589337 and TMC589354 after ascending single intakes. In addition, the safety, tolerability and behavior in the body after multipe dose…

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.

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ALTERNATING PANEL, SINGLE ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF JTK-656 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF JTK-656 IN HEALTHY MALE SUBJECTS

Primary :To investigate the safety and tolerability of ascending single oral doses of JTK-656 administered to healthy male subjectsSecondary:To determine the pharmacokinetics (PK) of ascending single oral doses of JTK-656 administered to healthy…

A Phase III, randomized, double-blind study of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects.

The primary objective of the trial is to demonstrate non-inferiority of treatment with TMC278 when administered as 75 mg q.d. compared to the control group (EFV) in regard to the proportion of virologic responders (plasma viral load < 50 HIV-…

A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

Main objective:To evaluate the non-inferiority of switching to the FTC/RPV/TAF FDC as compared to continuing FTC/RPV/TDF FDC in virologically suppressed HIV-1 infected subjects as determined by maintaining HIV-1 RNA < 50 copies/mL at Week 48…

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…

Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial (COVID-Compromise Study).

There have been reports of a more serious course of COVID-19 infections in patients with a reduced immune system, such as patients with congenital immune disorders, (haematological) malignancies or patients taking medications that suppress the…

A Phase 1, Single-blind, Randomized, Parallel-group Study in Healthy Participants to Investigate the Single-dose Pharmacokinetics, Safety and Tolerability of Rilpivirine After Subcutaneous Administration of a Rilpivirine Extended-Release Suspension alone, and of Rilpivirine and Cabotegravir After Co-administration with Cabotegravir Extended-Release Suspension

To characterize the single-dose pharmacokinetic (PK) of RPV after SC administration of RPV LA suspensions with different doses and/or different particle size (PS) to support further dose and formulation selection, in healthy adult participants.To…

Influencing Progression of Airway Disease in Primary Antibody Deficiency

This study has been transitioned to CTIS with ID 2024-513124-41-00 check the CTIS register for the current data. To show the protective value and to measure cost effectiveness of higher Ig dosing on progression of lung disease in PAD.

An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CDZ173 in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/
p110*-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

This trial is, along with establishment of the safety, tolerability and pharmacokinetics and -dynamics of CDZ173 in the target population, designed to select the optimal dose to normalize the function of the PI3K protein in patients with APDS/PASLI…

A phase IIa randomized, placebo controlled, double blinded study to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy.

To evaluate the safety and immunogenicity of iHIVARNA-01 as a new therapeutic vaccine in HIV infected patients.

Switching to Tenofovir Alafenamide Fumarate or ABACavir in patients with Tenofovir Disoproxil Fumarate associated eGFR decline. A randomized clinical trial.

To study the renal safety when HIV patients with TDF related renal toxicity switch to TAF compared to the current practice of switching to ABC.