10 results
1. To assess the effect of the switch from protease inhibitors to raltegravir on endothelial function. 2. To assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on…
Primary: To compare the pharmacokinetics of raltegravir 400 mg twice daily vs. ralte-gravir 800 mg once daily (QD) by intrasubject comparison. Secondary: To determine the efficacy of an antiretroviral regimen consisting of raltegravir 800mg QD,…
To assess non-inferiority of a regimen containing ritonavir-boosted elvitegravir versusraltegravir, each administered with a background regimen in HIV-1 infected,antiretroviral treatment-experienced adult subjects as determined by the proportion…
Primary: Antiviral efficacy after 48 weeks of treatment. Secundary: Antiviral efficacy after 24 weeks, safety and tolerability, resistance development, PK, incidence of HIV-associated conditions, gender-, race-, and/or HIV-1 subtype on response to…
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…
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…
To determine the effect of chronic use of ginkgo biloba on the single-dose pharma-cokinetics (AUC0-inf, AUC0-12, Cmax, C12) of raltegravir 400mg in healthy volunteers.
Primary objectiveTo determine the effect of steady state boceprevir on the pharmacokinetics (AUC0-12h, Cmax, C12h) of a single dose raltegravir.Secondary objectives:To determine the effect of a single dose raltegravir on the pharmacokinetics (AUC0-…
To develop a dosing nomogram of irinotecan in patients homozygous polymorphic for UGT1A1*28 and/or UGT1A1*93 in order to reduce the incidence of severe irinotecan-associated toxicity, defined as febrile neutropenia during the first two cycle of…
Primary:• To determine the safety and tolerability of FHD-286 when administered as an oral monotherapy in subjects with metastatic uveal melanoma (UM)• To identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of FHD-…