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Clinical trialNCT01475838CompletedPhase 3Interventional

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

SponsorGilead SciencesEnrollment438Acquired Immunodeficiency SyndromeHIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

99 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Austria
  • Innsbruck Medical University

    Innsbruck, Austria

  • Univ.-Kklinik Fuer Innere Medizin Iii

    Salzburg, Austria

  • Medical University of Vienna

    Vienna, Austria

  • Otto-Wagner-Spital

    Vienna, Austria

Belgium
  • Ucl Saint Luc

    Brussels, Belgium

  • University Hospital Ghent

    Ghent, Belgium

  • Chu Sart Tilman

    Liège, Belgium

Canada
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec, Canada

France
  • Chu de Besancon, Hopital Saint-Jacques

    Besançon, France

  • Hôpital de la Croix-Rousse

    Lyon, France

  • Chu Hôpital Gui de Chauliac

    Montpellier, France

  • Archet 1 Chu Nice Department of Infectology

    Nice, France

  • Hopital Saint Antoine

    Paris, France

  • Hôpital Bichat-Claude Bernard

    Paris, France

  • Maladies Infectieuses Dpt

    Paris, France

  • Saint-Louis Hospital

    Paris, France

  • Hôpital Tenon

    Paris, France

  • Hôpital Haut Lévêque

    Pessac, France

Germany
  • Epimed Gmbh

    Berlin, Germany

  • University of Bonn

    Bonn, Germany

  • Infektlonsambulanz Unlkllnik Koln

    Cologne, Germany

  • Universitätsklinikum Essen, Dermatologie, Hiv Ambulanz

    Essen, Germany

  • Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68

    Frankfurt, Germany

  • Ich Study Center

    Hamburg, Germany

  • Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum Des Uke Gmbh, Bereich Infektiologie

    Hamburg, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Infektionsambulanz, Med Poliklink, Klinikum Der Universitat Munchnen

    Munich, Germany

Italy
  • Ospedali Riuniti

    Bergamo, Italy

  • Clinic of Infectious Diseases, University of Milan-San Paolo Hospital

    Milan, Italy

  • Fondazione Centro San Raffaele

    Milan, Italy

  • Ospedale Luigi Sacco

    Milan, Italy

  • National Institute for Infectious Diseases "l. Spallanzani"

    Rome, Italy

  • University of Torino, Dept of Infectious Disease

    Torino, Italy

Portugal
  • Hhp Hospital de Cascais

    Alcabideche, Portugal

  • Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa

    Lisbon, Portugal

  • Hospital de Santa Maria-Chln, Epe

    Lisbon, Portugal

Puerto Rico
  • Clinical Research Puert Rico

    San Juan, Puerto Rico

  • University of Puerto Rico School of Medicine

    San Juan, Puerto Rico

Spain
  • Hospital General Universitario Alicante

    Alicante, Spain

59 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2011
Primary completion
30 Nov 2013
Completion
31 Dec 2014
Last update posted
8 Jun 2016
Registered enrollment
438
Registry id
NCT01475838

Cross-registrations

EU-CTR / CTIS (EudraCT)2011-004483-30

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.