13 results
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,…
To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remissionTo determine whether restarting of Imatinib in case of molecular relapse results in a…
This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib
The objective of this project is to investigate uptake, usability and acceptability of two hiv prevention interventions. These relate to the use of biomedical interventions, ie the provision of daily and intermittent PrEP to men who have sex with…
Primary:- To determine the MTD and/or a recommended phase II dose (RP2D) of BYL719 when administered orally in combination with imatinib 400 mg q.d.Secondary:- Assess the safety and tolerability profile of imatinib and BYL719 administered in…
The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…
To investigate the effect of expanded adipose-derived allogeneic adult stem cells (eASCs) on the inflammatory response to intravenous LPS in humans.
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…
Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
Primary:* Determine the maximum tolerated dose (MTD) and/or a recommended Phase II dose (RP2D) of BKM120 when administered in combination with imatinib 400 mg q.d.Secondary:* Assess the safety and tolerability profile of imatinib and BKM120…
Primary: To evaluate the long-term safety and tolerability of QTI571.Secondary: * Continue to evaluate the long-term efficacy of QTI571 as measured by the change in6MWD from baseline.* Continue to assess time to clinical worsening (TTCW) endpoints…
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-…
Primary- To demonstrate non-inferior antiviral activity of DTG + 3TC versus DTG + TDF/FTC at 48 weeks in HIV-1-infected, ART-naïve subjectsSecondary- To demonstrate the antiviral activity of DTG + 3TC versus DTG + TDF/FTC at 24, 96 and 144 weeks- To…