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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborator
NEAT - European AIDS Treatment Network

Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT01066962

First received: February 9, 2010
Last updated: November 5, 2013
Last Verified: November 2013
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : darunavir/ritonavir QD + raltegravir BID
Drug : darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

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

Enrollment: 800
Study Start Date: August 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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 < ~#o1~8 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

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT01066962

    Locations

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

    Sponsors and Collaborators

    French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
    NEAT - European AIDS Treatment Network

    Investigators

    Study Chair: François Raffi, Professor Nantes University Hospital
    More Information

    More Information


    Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)  
    ClinicalTrials.gov Identifier: NCT01066962   History of Changes  
    Other Study ID Numbers: 2009-015113-44  
      2009-015113-44  
    Study First Received: February 9, 2010  
    Last Updated: November 5, 2013  

    Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

    HIV-infected antiretroviral naïve subjects

    Additional relevant MeSH terms:
    HIV Infections
    Ritonavir
    Darunavir
    Tenofovir
    Raltegravir Potassium
    Emtricitabine

    ClinicalTrials.gov processed this data on October 20, 2017
    This information is provided by ClinicalTrials.gov.