Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects
- Conditions
- HIV Infections
- Interventions
- Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)Drug: darunavir/ritonavir QD + raltegravir BID
- Registration Number
- NCT01066962
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description darunavir/r + tenofovir/emtricitabine darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination) - darunavir/r + raltegravir darunavir/ritonavir QD + raltegravir BID -
- Primary Outcome Measures
Name Time Method Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components minimum 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (77)
Torvergata University
🇮🇹Rome, Italy
Hospital Clinic
🇪🇸Barcelona, Spain
University of Brescia
🇮🇹Brescia, Italy
Ospedale Santa Maria Annunziata
🇮🇹Florence, Italy
Luigi Sacco Hospital
🇮🇹Milano, Italy
Hôpital Gustave Dron
🇫🇷Tourcoing, France
Gemeinschaftspraxis Jessen-Jessen-Stein
🇩🇪Berlin, Germany
Laikon General Hospital
🇬🇷Athens, Greece
Hospital de la Santa Creu I Sant Pau.
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Med. Universitätsklinik I
🇩🇪Bonn, Germany
Ospedale "Amedeo di Savoia"
🇮🇹Turin, Italy
Saint Thomas hospital
🇬🇧London, United Kingdom
Hôpital La Pitié Salpétrière
🇫🇷Paris, France
San Paolo Hospital
🇮🇹Milan, Italy
Hôpital Foch
🇫🇷Suresnes, France
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Sahlgrenska hospital
🇸🇪Gothenburg, Sweden
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Saint Stephen's Centre
🇬🇧London, United Kingdom
Hospital Carlos III
🇪🇸Madrid, Spain
Sapienza Universita di Roma
🇮🇹Rome, Italy
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milan, Italy
Istituto Naziona e per le Malattie "Lazzaro Spallanzani"
🇮🇹Rome, Italy
Hôpital Bicêtre
🇫🇷Le Kremlin Bicêtre, France
Hôpital Gui de Chauliac
🇫🇷Montpellier, France
Hôpital Purpan
🇫🇷Toulouse, France
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinik Köln
🇩🇪Köln, Germany
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
Otto Wagner Spital mit Pflegezentrum
🇦🇹Wien, Austria
UZ Gent
🇧🇪Gent, Belgium
Rigshospitalet
🇩🇰Copenhagen, Denmark
Hôpital Pellegrin
🇫🇷Bordeaux, France
Hôpital Saint André
🇫🇷Bordeaux, France
Hôpital Pierre Zobda-Quitman
🇫🇷Fort de France, France
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Hôpital Henri Mondor
🇫🇷Créteil, France
Hôpital du Bocage
🇫🇷Dijon, France
CHD de la Roche sur Yon
🇫🇷La Roche sur Yon, France
Hôpital Bichat
🇫🇷Paris, France
Hôpital Européen Georges Pompidou (HEGP)
🇫🇷Paris, France
Hôpital de l'Hôtel Dieu
🇫🇷Nantes, France
Hôpital Saint Louis
🇫🇷Paris, France
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital Pontchaillou
🇫🇷Rennes, France
ICH study centre
🇩🇪Hamburg, Germany
Asklepios-Klinik St. Georg
🇩🇪Hamburg, Germany
Klinikum der Johann Wolfgang Goethe Universität
🇩🇪Frankfurt, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Saint Laszlo Hospital
🇭🇺Budapest, Hungary
Hospital Santa Maria
🇵🇹Lisbon, Portugal
Attikon University Hospital
🇬🇷Athens, Greece
Evaggelismos General Hospital
🇬🇷Athens, Greece
Mater Misericordiae
🇮🇪Dublin, Ireland
Hospital of Infectious Diseases of Warsaw
🇵🇱Warsaw, Poland
AMC
🇳🇱Amsterdam, Netherlands
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Karolinska hospital
🇸🇪Stockholm, Sweden
Southmead Hospital
🇬🇧Bristol, United Kingdom
Venhälsan hospital
🇸🇪Stockholm, Sweden
Saint Mary's hospital
🇬🇧London, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Mortimer market centre
🇬🇧London, United Kingdom
ITZ Antwerpen
🇧🇪Antwerpen, Belgium
Jan van Goyen Medical Center
🇳🇱Amsterdam, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Hospital de Joaquim Urbano
🇵🇹Porto, Portugal
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Wien, Austria
Hospital de Curry Cabral
🇵🇹Lisbon, Portugal
CHU Saint Pierre
🇧🇪Brussels, Belgium
St James's Hospital
🇮🇪Dublin, Ireland