Back to resultsStudy of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects (ANRS 143)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
darunavir/ritonavir QD + raltegravir BID
darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-infected antiretroviral naïve subjects
Eligibility 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 < 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
Sites / Locations
- Allgemeines Krankenhaus der Stadt Wien
- Otto Wagner Spital mit Pflegezentrum
- ITZ Antwerpen
- CHU Saint Pierre
- UZ Gent
- Rigshospitalet
- Hvidovre Hospital
- Hôpital Pellegrin
- Hôpital Saint André
- Hôpital Henri Mondor
- Hôpital du Bocage
- Hôpital Pierre Zobda-Quitman
- CHD de la Roche sur Yon
- Hôpital Bicêtre
- Hôpital Gui de Chauliac
- Hôpital de l'Hôtel Dieu
- Hôpital Bichat
- Hôpital Européen Georges Pompidou (HEGP)
- Hôpital La Pitié Salpétrière
- Hôpital Saint Antoine
- Hôpital Saint Louis
- Hôpital Pontchaillou
- Hôpital Foch
- Hôpital Purpan
- Hôpital Gustave Dron
- Gemeinschaftspraxis Jessen-Jessen-Stein
- Med. Universitätsklinik I
- Universitätsklinikum Essen
- Klinikum der Johann Wolfgang Goethe Universität
- Asklepios-Klinik St. Georg
- ICH study centre
- Medizinische Hochschule Hannover
- Universitätsklinik Köln
- Attikon University Hospital
- Evaggelismos General Hospital
- Laikon General Hospital
- Saint Laszlo Hospital
- Mater Misericordiae
- St James's Hospital
- University of Brescia
- Ospedale Santa Maria Annunziata
- Luigi Sacco Hospital
- Fondazione Centro San Raffaele del Monte Tabor
- San Paolo Hospital
- Istituto Naziona e per le Malattie "Lazzaro Spallanzani"
- Sapienza Universita di Roma
- Torvergata University
- Ospedale "Amedeo di Savoia"
- AMC
- Jan van Goyen Medical Center
- Rijnstate Hospital
- Hospital of Infectious Diseases of Warsaw
- Hospital de Curry Cabral
- Hospital Santa Maria
- Hospital de Joaquim Urbano
- Hospital General Universitario de Alicante
- Hospital Clinic
- Hospital de la Santa Creu I Sant Pau.
- Hospital del Mar
- Hospital Germans Trias i Pujol
- Hospital Carlos III
- Hospital Clinico San Carlos
- Hospital Gregorio Marañon
- Hospital Universitario La Paz
- Hospital Universitario Virgen de la Victoria
- Hospital Universitario La Fe
- Sahlgrenska hospital
- Karolinska hospital
- Venhälsan hospital
- Royal Bournemouth Hospital
- Southmead Hospital
- Western General Hospital
- Mortimer market centre
- Royal Free Hospital
- Saint Mary's hospital
- Saint Stephen's Centre
- Saint Thomas hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
darunavir/r + tenofovir/emtricitabine
darunavir/r + raltegravir
Arm Description
Outcomes
Primary Outcome Measures
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
Secondary Outcome Measures
Full Information
NCT ID
NCT01066962
First Posted
February 9, 2010
Last Updated
November 5, 2013
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
NEAT - European AIDS Treatment Network
1. Study Identification
Unique Protocol Identification Number
NCT01066962
Brief Title
Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects
Acronym
ANRS 143
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
NEAT - European AIDS Treatment Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-infected antiretroviral naïve subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
darunavir/r + tenofovir/emtricitabine
Arm Type
Active Comparator
Arm Title
darunavir/r + raltegravir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
darunavir/ritonavir QD + raltegravir BID
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
Time Frame
minimum 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Raffi, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Wien
Country
Austria
Facility Name
Otto Wagner Spital mit Pflegezentrum
City
Wien
Country
Austria
Facility Name
ITZ Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
CHU Saint Pierre
City
Brussels
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
Facility Name
Hôpital Pellegrin
City
Bordeaux
Country
France
Facility Name
Hôpital Saint André
City
Bordeaux
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Facility Name
Hôpital du Bocage
City
Dijon
Country
France
Facility Name
Hôpital Pierre Zobda-Quitman
City
Fort de France
Country
France
Facility Name
CHD de la Roche sur Yon
City
La Roche sur Yon
Country
France
Facility Name
Hôpital Bicêtre
City
Le Kremlin Bicêtre
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
Country
France
Facility Name
Hôpital de l'Hôtel Dieu
City
Nantes
Country
France
Facility Name
Hôpital Bichat
City
Paris
Country
France
Facility Name
Hôpital Européen Georges Pompidou (HEGP)
City
Paris
Country
France
Facility Name
Hôpital La Pitié Salpétrière
City
Paris
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
Hôpital Foch
City
Suresnes
Country
France
Facility Name
Hôpital Purpan
City
Toulouse
Country
France
Facility Name
Hôpital Gustave Dron
City
Tourcoing
Country
France
Facility Name
Gemeinschaftspraxis Jessen-Jessen-Stein
City
Berlin
Country
Germany
Facility Name
Med. Universitätsklinik I
City
Bonn
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe Universität
City
Frankfurt
Country
Germany
Facility Name
Asklepios-Klinik St. Georg
City
Hamburg
Country
Germany
Facility Name
ICH study centre
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Universitätsklinik Köln
City
Köln
Country
Germany
Facility Name
Attikon University Hospital
City
Athens
Country
Greece
Facility Name
Evaggelismos General Hospital
City
Athens
Country
Greece
Facility Name
Laikon General Hospital
City
Athens
Country
Greece
Facility Name
Saint Laszlo Hospital
City
Budapest
Country
Hungary
Facility Name
Mater Misericordiae
City
Dublin
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
Country
Ireland
Facility Name
University of Brescia
City
Brescia
Country
Italy
Facility Name
Ospedale Santa Maria Annunziata
City
Florence
Country
Italy
Facility Name
Luigi Sacco Hospital
City
Milano
Country
Italy
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milan
Country
Italy
Facility Name
San Paolo Hospital
City
Milan
Country
Italy
Facility Name
Istituto Naziona e per le Malattie "Lazzaro Spallanzani"
City
Rome
Country
Italy
Facility Name
Sapienza Universita di Roma
City
Rome
Country
Italy
Facility Name
Torvergata University
City
Rome
Country
Italy
Facility Name
Ospedale "Amedeo di Savoia"
City
Turin
Country
Italy
Facility Name
AMC
City
Amsterdam
Country
Netherlands
Facility Name
Jan van Goyen Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands
Facility Name
Hospital of Infectious Diseases of Warsaw
City
Warsaw
Country
Poland
Facility Name
Hospital de Curry Cabral
City
Lisbon
Country
Portugal
Facility Name
Hospital Santa Maria
City
Lisbon
Country
Portugal
Facility Name
Hospital de Joaquim Urbano
City
Porto
Country
Portugal
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu I Sant Pau.
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital Carlos III
City
Madrid
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Sahlgrenska hospital
City
Gothenburg
Country
Sweden
Facility Name
Karolinska hospital
City
Stockholm
Country
Sweden
Facility Name
Venhälsan hospital
City
Stockholm
Country
Sweden
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Mortimer market centre
City
London
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Saint Mary's hospital
City
London
Country
United Kingdom
Facility Name
Saint Stephen's Centre
City
London
Country
United Kingdom
Facility Name
Saint Thomas hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33794182
Citation
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. Erratum In: Lancet HIV. 2021 Dec;8(12):e734.
Results Reference
derived
PubMed Identifier
30365452
Citation
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.
Results Reference
derived
PubMed Identifier
26520926
Citation
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.
Results Reference
derived
PubMed Identifier
25103176
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects
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