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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066962
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : November 6, 2013
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)

Brief Summary:

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 or disease Intervention/treatment Phase
HIV Infections Drug: darunavir/ritonavir QD + raltegravir BID Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
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)
Study Start Date : August 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066962

  Hide Study Locations
Allgemeines Krankenhaus der Stadt Wien
Wien, Austria
Otto Wagner Spital mit Pflegezentrum
Wien, Austria
ITZ Antwerpen
Antwerpen, Belgium
CHU Saint Pierre
Brussels, Belgium
UZ Gent
Gent, Belgium
Copenhagen, Denmark
Hvidovre Hospital
Hvidovre, Denmark
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
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
Attikon University Hospital
Athens, Greece
Evaggelismos General Hospital
Athens, Greece
Laikon General Hospital
Athens, Greece
Saint Laszlo Hospital
Budapest, Hungary
Mater Misericordiae
Dublin, Ireland
St James's Hospital
Dublin, Ireland
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
Amsterdam, Netherlands
Jan van Goyen Medical Center
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Hospital of Infectious Diseases of Warsaw
Warsaw, Poland
Hospital de Curry Cabral
Lisbon, Portugal
Hospital Santa Maria
Lisbon, Portugal
Hospital de Joaquim Urbano
Porto, Portugal
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
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
Study Chair: François Raffi, Professor Nantes University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) Identifier: NCT01066962     History of Changes
Other Study ID Numbers: 2009-015113-44
2009-015113-44 ( EudraCT Number )
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors