INTRODUCCIÓN WP1

Interventional and strategic studies addressed to optimize the utilization of antiretroviral treatment (ART), including pharmacokinetics, pharmacogenomics, pharmacoeconomy, resistance and tropism

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(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.