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

This study has been completed.
Sponsor:
Collaborator:
NEAT - European AIDS Treatment Network
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01066962
First received: February 9, 2010
Last updated: November 5, 2013
Last verified: November 2013

February 9, 2010
November 5, 2013
August 2010
October 2013   (final data collection date for primary outcome measure)
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components [ Time Frame: minimum 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01066962 on ClinicalTrials.gov Archive Site
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Study of Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir in HIV-infected Antiretroviral naïve Subjects
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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)

  • 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)

  • Active Comparator: darunavir/r + tenofovir/emtricitabine
    Intervention: Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)
  • Experimental: darunavir/r + raltegravir
    Intervention: Drug: darunavir/ritonavir QD + raltegravir BID
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Netherlands,   Poland,   Portugal,   Spain,   Sweden,   United Kingdom
 
NCT01066962
2009-015113-44, 2009-015113-44
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
NEAT - European AIDS Treatment Network
Study Chair: François Raffi, Professor Nantes University Hospital
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP