Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects
NCT ID: NCT01066962
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2010-08-31
2013-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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darunavir/r + tenofovir/emtricitabine
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)
darunavir/r + raltegravir
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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NEAT - European AIDS Treatment Network
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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François Raffi, Professor
Role: STUDY_CHAIR
Nantes University Hospital
Locations
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Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
Otto Wagner Spital mit Pflegezentrum
Vienna, , Austria
ITZ Antwerpen
Antwerp, , Belgium
CHU Saint Pierre
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Rigshospitalet
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
Universitätsklinik Köln
Cologne, , 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
Hanover, , 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
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
San Paolo Hospital
Milan, , Italy
Luigi Sacco 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
AMC
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
Málaga, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Sahlgrenska hospital
Gothenburg, , Sweden
Karolinska hospital
Stockholm, , Sweden
Venhälsan hospital
Stockholm, , Sweden
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
Countries
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References
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Esteban-Cantos A, Rodriguez-Centeno J, Barruz P, Alejos B, Saiz-Medrano G, Nevado J, Martin A, Gaya F, De Miguel R, Bernardino JI, Montejano R, Mena-Garay B, Cadinanos J, Florence E, Mulcahy F, Banhegyi D, Antinori A, Pozniak A, Wallet C, Raffi F, Rodes B, Arribas JR; NEAT001/ANRS143 Study Group. Epigenetic age acceleration changes 2 years after antiretroviral therapy initiation in adults with HIV: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2021 Apr;8(4):e197-e205. doi: 10.1016/S2352-3018(21)00006-0.
Ammassari A, Stohr W, Antinori A, Molina JM, Schwimmer C, Domingo P, Thalme A, Di Pietro M, Wallet C, Pozniak A, Richert L, Raffi F; NEAT001/ANRS143 Trial Study Group. Patient Self-Reported Adherence to Ritonavir-Boosted Darunavir Combined With Either Raltegravir or Tenofovir Disoproxil Fumarate/Emtricitabine in the NEAT001/ANRS143 Trial. J Acquir Immune Defic Syndr. 2018 Dec 1;79(4):481-490. doi: 10.1097/QAI.0000000000001834.
Bernardino JI, Mocroft A, Mallon PW, Wallet C, Gerstoft J, Russell C, Reiss P, Katlama C, De Wit S, Richert L, Babiker A, Buno A, Castagna A, Girard PM, Chene G, Raffi F, Arribas JR; NEAT001/ANRS143 Study Group. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015 Nov;2(11):e464-73. doi: 10.1016/S2352-3018(15)00181-2. Epub 2015 Sep 30.
Raffi F, Babiker AG, Richert L, Molina JM, George EC, Antinori A, Arribas JR, Grarup J, Hudson F, Schwimmer C, Saillard J, Wallet C, Jansson PO, Allavena C, Van Leeuwen R, Delfraissy JF, Vella S, Chene G, Pozniak A; NEAT001/ANRS143 Study Group. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014 Nov 29;384(9958):1942-51. doi: 10.1016/S0140-6736(14)61170-3. Epub 2014 Aug 4.
Other Identifiers
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2009-015113-44
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2009-015113-44
Identifier Type: -
Identifier Source: org_study_id