Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects (ANRS 143)

November 5, 2013 updated by: ANRS, Emerging Infectious Diseases

An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001)

The triple therapy darunavir/r + tenofovir/emtricitabine is likely to become a relevant first-line treatment option in the years to come. The dual combination of boosted darunavir + raltegravir is an innovative treatment option that combines two potent new antiretroviral drugs, one of which belongs to a new drug class (integrase inhibitor). The expected efficacy profile of this combination is promising. Moreover, this combination might have a better tolerance profile and has the advantage of sparing the NRTI class.

In the context of tenofovir/emtricitabine currently being a reference backbone in first-line antiretroviral regimens, we hypothesise that, in combination with darunavir/r, raltegravir may be an alternative option if its efficacy is non-inferior to tenofovir/emtricitabine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • Allgemeines Krankenhaus der Stadt Wien
      • Wien, Austria
        • Otto Wagner Spital mit Pflegezentrum
  • Belgium
      • Antwerpen, Belgium
        • ITZ Antwerpen
      • Brussels, Belgium
        • CHU Saint Pierre
      • Gent, Belgium
        • UZ Gent
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
      • Hvidovre, Denmark
        • Hvidovre Hospital
  • France
      • Bordeaux, France
        • Hopital Saint André
      • Bordeaux, France
        • Hôpital Pellegrin
      • Créteil, France
        • Hopital Henri Mondor
      • Dijon, France
        • Hôpital du Bocage
      • Fort de France, France
        • Hôpital Pierre Zobda-Quitman
      • La Roche sur Yon, France
        • CHD de la Roche Sur Yon
      • Le Kremlin Bicêtre, France
        • Hôpital Bicêtre
      • Montpellier, France
        • Hopital Gui de Chauliac
      • Nantes, France
        • Hôpital de l'Hôtel Dieu
      • Paris, France
        • Hôpital Bichat
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France
        • Hopital Saint Louis
      • Paris, France
        • Hôpital Européen Georges Pompidou (HEGP)
      • Paris, France
        • Hôpital La Pitié Salpêtrière
      • Rennes, France
        • Hôpital Pontchaillou
      • Suresnes, France
        • Hopital Foch
      • Toulouse, France
        • Hopital Purpan
      • Tourcoing, France
        • Hôpital Gustave Dron
  • Germany
      • Berlin, Germany
        • Gemeinschaftspraxis Jessen-Jessen-Stein
      • Bonn, Germany
        • Med. Universitätsklinik I
      • Essen, Germany
        • Universitätsklinikum Essen
      • Frankfurt, Germany
        • Klinikum Der Johann Wolfgang Goethe Universitat
      • Hamburg, Germany
        • Asklepios-Klinik St. Georg
      • Hamburg, Germany
        • ICH study centre
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Köln, Germany
        • Universitätsklinik Köln
  • Greece
      • Athens, Greece
        • Evaggelismos General Hospital
      • Athens, Greece
        • Attikon University Hospital
      • Athens, Greece
        • Laikon General Hospital
  • Hungary
      • Budapest, Hungary
        • Saint Laszlo Hospital
  • Ireland
      • Dublin, Ireland
        • St James's Hospital
      • Dublin, Ireland
        • Mater Misericordiae
  • Italy
      • Brescia, Italy
        • University of Brescia
      • Florence, Italy
        • Ospedale Santa Maria Annunziata
      • Milan, Italy
        • Fondazione Centro San Raffaele del Monte Tabor
      • Milan, Italy
        • San Paolo Hospital
      • Milano, Italy
        • Luigi Sacco Hospital
      • Rome, Italy
        • Istituto Naziona e per le Malattie "Lazzaro Spallanzani"
      • Rome, Italy
        • Sapienza università di Roma
      • Rome, Italy
        • Torvergata University
      • Turin, Italy
        • Ospedale "Amedeo di Savoia"
  • Netherlands
      • Amsterdam, Netherlands
        • AMC
      • Amsterdam, Netherlands
        • Jan van Goyen Medical Center
      • Arnhem, Netherlands
        • Rijnstate Hospital
  • Poland
      • Warsaw, Poland
        • Hospital of Infectious Diseases of Warsaw
  • Portugal
      • Lisbon, Portugal
        • Hospital Santa Maria
      • Lisbon, Portugal
        • Hospital de Curry Cabral
      • Porto, Portugal
        • Hospital de Joaquim Urbano
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Clinic
      • Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau.
      • Madrid, Spain
        • Hospital Gregorio Marañon
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Carlos III
      • Malaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain
        • Hospital Universitario la Fe
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska Hospital
      • Stockholm, Sweden
        • Karolinska hospital
      • Stockholm, Sweden
        • Venhälsan hospital
  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom
        • Southmead Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital
      • London, United Kingdom
        • Mortimer Market Centre
      • London, United Kingdom
        • Royal Free Hospital
      • London, United Kingdom
        • Saint Mary's Hospital
      • London, United Kingdom
        • Saint Stephen's Centre
      • London, United Kingdom
        • Saint Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with confirmed HIV infection
  • Age ≥ 18 years
  • Written informed consent
  • Male patient or non-pregnant, non-lactating female
  • No previous treatment with any antiretroviral drugs
  • HIV-1 RNA > 1000 copies/ml
  • Indication to start an antiretroviral treatment as long as subject has also a CD4 cell count ≤ 500/mm3 either at screening or on a sample taken within 3 months before screening
  • No major IAS-USA mutations on genotypic testing at the screening visit or on any historical genotype, if available

Non-inclusion Criteria:

  • Woman without effective contraception method (recommended contraception during the trial is mechanical + a second method other than an oral contraceptive)
  • Pregnant or breastfeeding woman
  • Woman expecting to conceive during the study
  • HIV-2 co-infection
  • Creatinine clearance < 60 ml/mn (Cockcroft & Gault equation), alkaline phosphatase, ASAT, or ALAT ≥ 5 ULN
  • Patient with significant impairment of hepatic function, defined as serum albumin < 2.8 g/dl or INR > 1.7 or presence of ascites, in the absence of another explanation for the abnormal finding
  • CD4 > 500/mm3 at screening, except in case of symptomatic HIV disease (defined by conditions qualifying for CDC category B or C) or CD4 ≤ 500/mm3 on a sample taken within 3 months before screening.
  • Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or protease inhibitors on genotypic testing at screening
  • Mycobacteriosis under treatment
  • Malignancy requiring chemotherapy or radiotherapy
  • Positive HBs Ag
  • HCV infection for which specific treatment is ongoing or planned during the first year on trial treatment
  • Known hypersensitivity to one of the trial drugs or its excipients
  • Contraindicated concomitant treatment
  • Anticipated non-compliance with the protocol
  • Participation in another clinical trial with an on-going exclusion period at screening
  • Subject under legal guardianship or incapacitation
  • Subject, who in the opinion of the investigator, is unable to complete the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: darunavir/r + tenofovir/emtricitabine
Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)

darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD)

ritonavir 100 mg, 1 tablet once daily (QD)

tenofovir/emtricitabine 245/200 mg, fixed dose combination, 1 tablet once daily (QD)
Experimental: darunavir/r + raltegravir
Drug: darunavir/ritonavir QD + raltegravir BID

darunavir 800 mg, i.e. 2 tablets of 400 mg once daily (QD)

ritonavir 100 mg, 1 tablet once daily (QD)

raltegravir 400 mg, 1 tablet twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
Time Frame: minimum 2 years
minimum 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

NEAT - European AIDS Treatment Network

Investigators

  • Study Chair: François Raffi, Professor, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-015113-44 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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