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

November 5, 2013 updated by: ANRS, Emerging Infectious Diseases

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria
        • Allgemeines Krankenhaus der Stadt Wien
      • Wien, Austria
        • Otto Wagner Spital mit Pflegezentrum
  • Belgium
      • Antwerpen, Belgium
        • ITZ Antwerpen
      • Brussels, Belgium
        • CHU Saint Pierre
      • Gent, Belgium
        • UZ Gent
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
      • Hvidovre, Denmark
        • Hvidovre Hospital
  • France
      • Bordeaux, France
        • Hopital Saint André
      • Bordeaux, France
        • Hôpital Pellegrin
      • Créteil, France
        • Hôpital Henri Mondor
      • Dijon, France
        • Hôpital du Bocage
      • Fort de France, France
        • Hôpital Pierre Zobda-Quitman
      • La Roche sur Yon, France
        • CHD de la Roche Sur Yon
      • Le Kremlin Bicêtre, France
        • Hôpital Bicêtre
      • Montpellier, France
        • Hopital Gui de Chauliac
      • Nantes, France
        • Hôpital de l'Hôtel Dieu
      • Paris, France
        • Hôpital Bichat
      • Paris, France
        • Hôpital Saint Antoine
      • Paris, France
        • Hopital Saint Louis
      • Paris, France
        • Hopital Europeen Georges Pompidou (HEGP)
      • Paris, France
        • Hôpital la pitié salpètrière
      • Rennes, France
        • Hopital Pontchaillou
      • Suresnes, France
        • Hopital Foch
      • Toulouse, France
        • Hopital Purpan
      • Tourcoing, France
        • Hôpital Gustave Dron
  • Germany
      • Berlin, Germany
        • Gemeinschaftspraxis Jessen-Jessen-Stein
      • Bonn, Germany
        • Med. Universitätsklinik I
      • Essen, Germany
        • Universitätsklinikum Essen
      • Frankfurt, Germany
        • Klinikum Der Johann Wolfgang Goethe Universitat
      • Hamburg, Germany
        • Asklepios-Klinik St. Georg
      • Hamburg, Germany
        • ICH study centre
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Köln, Germany
        • Universitätsklinik Köln
  • Greece
      • Athens, Greece
        • Evaggelismos General Hospital
      • Athens, Greece
        • Attikon University Hospital
      • Athens, Greece
        • Laikon General Hospital
  • Hungary
      • Budapest, Hungary
        • Saint Laszlo Hospital
  • Ireland
      • Dublin, Ireland
        • St James's Hospital
      • Dublin, Ireland
        • Mater Misericordiae
  • Italy
      • Brescia, Italy
        • University of Brescia
      • Florence, Italy
        • Ospedale Santa Maria Annunziata
      • Milan, Italy
        • Fondazione Centro San Raffaele del Monte Tabor
      • Milan, Italy
        • San Paolo Hospital
      • Milano, Italy
        • Luigi Sacco Hospital
      • Rome, Italy
        • Istituto Naziona e per le Malattie "Lazzaro Spallanzani"
      • Rome, Italy
        • Sapienza università di Roma
      • Rome, Italy
        • Torvergata University
      • Turin, Italy
        • Ospedale "Amedeo di Savoia"
  • Netherlands
      • Amsterdam, Netherlands
        • AMC
      • Amsterdam, Netherlands
        • Jan van Goyen Medical Center
      • Arnhem, Netherlands
        • Rijnstate Hospital
  • Poland
      • Warsaw, Poland
        • Hospital of Infectious Diseases of Warsaw
  • Portugal
      • Lisbon, Portugal
        • Hospital Santa Maria
      • Lisbon, Portugal
        • Hospital de Curry Cabral
      • Porto, Portugal
        • Hospital de Joaquim Urbano
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Clinic
      • Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau.
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Carlos III
      • Malaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Valencia, Spain
        • Hospital Universitario la Fe
  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska Hospital
      • Stockholm, Sweden
        • Karolinska hospital
      • Stockholm, Sweden
        • Venhälsan hospital
  • United Kingdom
      • Bournemouth, United Kingdom
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom
        • Southmead Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital
      • London, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
Time Frame: minimum 2 years
minimum 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ANRS, Emerging Infectious Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NEAT - European AIDS Treatment Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: François Raffi, Professor, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009-015113-44 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings