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

Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

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

Phase: Phase 3

Status: Completed

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

Official(s) and/or principal investigator(s):
François Raffi, Professor, Study Chair, Affiliation: Nantes University Hospital


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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,


- 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


- Subject under legal guardianship or incapacitation

- Subject, who in the opinion of the investigator, is unable to complete the study


Locations and Contacts

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

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

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

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, Malaga, 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

Additional Information

Starting date: August 2010
Last updated: November 5, 2013

Page last updated: August 23, 2015

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