WP1's trials
Interventional and strategic studies addressed to optimize the utilization of antiretroviral treatment (ART), including pharmacokinetics, pharmacogenomics, pharmacoeconomy, resistance and tropism
(Pending). D2 Study.
Efficacy and safety of Dolutegravir + Darunavir/Cobicistat as a simplification strategy vs optimized therapy in virologically suppressed HIV-1 infected patients with resistance mutations to multiple drugs.
Leader Researcher: (Pending).
Sponsor: Without sponsors.
Status: Pending start.
RIS-EST47. DUAL Study.
Study to assess Darunavir/Ritonavir + Lamivudine therapy once a day vs maintaining Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine once a day in HIV infected patients with viral suppression.
Leader Researcher: José R Arribas, Federico Pulido, Esteban Ribera.
Sponsor: Fundación SEIMC-GESIDA.
Status: Completed.
RIS-EST45. ETRAL Study.
Study to assess the capacity of dual combination Raltegravir/Etravirine to maintain undetectable HIV-1 viral load in patients aged 45 receiving previously boosted PI therapy.
Leader Researcher: Esteban Martínez.
Sponsor: ANRS.
Status: Completed.
RIS-EST46. RALAM Study.
Study to assess the effects of switching from a fixed dosage combination of a Raltegravir + Lamivudine regimen vs one pill therapy.
Leader Researcher: Esteban Martínez.
Sponsor: Fundació Clínic Recerca Biomédica.
Status: Completed.
RIS-EST42. VIRECURE Study.
Study to assess the capacity of dual combination Raltegravir/Etravirine to maintain undetectable HIV-1 viral load in patients aged 45 receiving previously boosted PI therapy.
Leader Researcher: Josep María Miró.
Sponsor: Fundació Clínic Recerca Biomédica.
Status: Completed.
RIS-EST41. INDOOR Study.
Study of HIV reservoirs dynamics after switching therapy to Dolutegravir in patients with a regimen based on two NRTI and one PI. An open randomised phase IV clinical trial.
Leader Researcher: Manel Crespo / Esteban Ribera.
Sponsor: Fundació Vall d’Hebrón Institut de Recerca.
Status: Pending data analysis.
RIS-EST40. EVITA’s Study.
Clinical trial for defining Tenofovir DP concentration in seminal cells and assessing the semen quality in HIV infected patients receiving therapy including Tenofovir Alafenamide.
Leader Researcher: Daniel Podzamczer / Arkaitz Imaz.
Sponsor: Fundació Lluita Contra la SIDA.
Status: Completed.
RIS-EST39. SCALA Study.
Assessment of viral suppression in cerebrospinal fluid of HIV infected patients receiving Atazanavir /Ritonavir and Lamivudine therapy.
Leader Researcher: Daniel Podzamczer / Arkaitz Imaz.
Sponsor: IDIBELL-Hospital Universitari de Bellvitge.
Status: Completed.
RIS-EST35. Naïve Alternativo Study.
Cost-effectiveness study of three antiretroviral therapy regimens (Stribild® vs Kivexa + Rilpivirine vs Darunavir/Ritonavir + Lamivudine) in naïve patients after 48 weeks of therapy.
Leader Researcher: Josep Mallolas.
Sponsor: (Without sponsors).
Status: Ongoing.
RIS-EST34. DOLAM Study.
Simplification of antiretroviral therapy through regimens based on Dolutegravir: Dolutegravir + Lamivudine bitherapy or Dolutegravir monotherapy.
Leader Researcher: Esteban Martínez.
Sponsor: Own funds HIV Units Hospital Trias i Pujol and Hospital Clínic.
Status: Monotherapy study completed, sub-study ongoing..
RIS-EST22. BIMARTHE Study.
Clinical trial to assess the efficacy of the dual therapy with Maraviroc and Darunavir boosted with Ritonavir for early rescue treatment in HIV patients.
Leader Researcher: Manel Crespo/Esteban Ribera.
Sponsor: NEAT and SSAT.
Status: Ongoing.
RIS-EST31. NEAT22-SSAT 060 Study.
Open randomised clinical trial to assess cardiovascular risk of immediate or deferred switching from a boosted IP to Dolutegravir (DGV) in HIV patients with consistent virological suppression.
Leader Researcher: Josep María Gatell.
Sponsor: NEAT and SSAT.
Status: Ongoing.
RIS-EST15. Atri-week Study.
Clinical trial to assess the effects of the reduction in the fixed dosage of the combination EFV/TDF/FTC in patients with undetectable plasmatic viral load.
Leader Researcher: Esteban Martínez.
Sponsor: Fundació Clínic Recerca Biomédica.
Status: Completed.
RIS-EST14. Advanz-4 Study.
Clinical trial to assess the immunological and virological response, efficacy and safety of two antiretroviral regimens (Truvada® and Raltegravir vs Truvada® and Efavirenz or Darunavir/Ritonavir) in previously untreated patients with chronic HIV infection and CD4 count below 100 cells/mm3.
Leader Researcher: Josep María Miró.
Sponsor: Fundació Clínic Recerca Biomédica.
Status: Ongoing.