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Clinical trialNCT01252940CompletedPhase 3Interventional

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

SponsorGilead SciencesEnrollment482HIV-1 Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

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

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

Austria
  • Univ.-Kklinik Fuer Innere Medizin Iii

    Salzberg, Austria

  • Lkh Graz West

    Styria, Austria

  • 2.Interne Lungenabteilung Otto Wagner Spital

    Vienna, Austria

  • Dept. of Dermatology, Div. of Immunology,

    Vienna, Austria

  • Private Office

    Vienna, Austria

Belgium
  • Chu Saint-Pierre University Hospital

    Brussels, Belgium

  • University Hospitals Leuven

    Flemish Brabant, Belgium

  • Universitaire Ziekenhuis Gent

    Ghent, Belgium

Canada
  • Downtown Infectious Disease Clinic - Univ of Bc

    Vancouver, British Columbia, Canada

  • Maple Leaf Research

    Toronto, Ontario, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

  • Clinique Medicale Du Quartier Latin

    Montreal, Quebec, Canada

  • Winnipeg Regional Health Authority

    Winnipeg, Canada

France
  • Hôpital Hôtel-Dieu

    Lyon, France

  • Infectiologie - 7ème Ouest - Chu Hotel Dieu

    Nantes, France

  • Archet 1 Chu de Nice - 6ème Niveau - Infectiology

    Nice, France

  • Bichat Hospital

    Paris, France

  • Department of Infectious Diseases, Saint-Louis Hospital

    Paris, France

  • Hopital Tenon

    Paris, France

  • Hôpital Saint Antoine, Servuce de Maladies Infectieuses

    Paris, France

  • Maladies Infectieuses Dpt

    Paris, France

  • Hôpital Haut Levêque

    Pessac, France

Germany
  • Epimed Gmbh

    Berlin, Germany

  • University of Bonn, Dep. of Internal Medicine I, Hiv-Outpatient Clinic

    Bonn, Germany

  • University of Cologne, Department of Internal Medicine

    Cologne, Germany

  • Center for Hiv and Hepatogastroenterology

    Düsseldorf, Germany

  • Infectio Research

    Frankfurt, Germany

  • Ich Study Center Hamburg

    Hamburg, Germany

  • University Medical Center Hamburg - Eppendorf

    Hamburg, Germany

Italy
  • Ospedali Riuniti

    Bergamo, Italy

  • Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

    Milan, Italy

  • Azienda Ospedaliera San Paolo, Mallattie Infettive E Tropicali

    Milan, Italy

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, Italy

  • National Institute for Infectious Diseases "l. Spallanzani" Irccs

    Rome, Italy

Puerto Rico
  • Clinical Research Puerto Rico, Inc.

    San Juan, Puerto Rico

Spain
  • Hospital Clinic I Provincial

    Barcelona, Spain

  • Hospital Germans Trias I Pujol

    Barcelona, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Spain

  • Hospital Ramon Y Cajal

    Madrid, Spain

United Kingdom
  • Brighton and Sussex University Hospitals Nhs Trust

    Brighton, East Sussex, United Kingdom

71 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 2010
Primary completion
31 Jan 2012
Completion
31 Oct 2014
Last update posted
4 Dec 2015
Registered enrollment
482
Registry id
NCT01252940

Cross-registrations

EU-CTR / CTIS (EudraCT)2010-023178-37

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.