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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
800
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)
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)
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
Otto Wagner Spital mit Pflegezentrum
Vienna, Austria
ITZ Antwerpen
Antwerp, Belgium
CHU Saint Pierre
Brussels, Belgium
UZ Gent
Ghent, Belgium
Rigshospitalet
Copenhagen, Denmark
Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components
Time frame: minimum 2 years
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Hvidovre Hospital
Hvidovre, Denmark
Hôpital Pellegrin
Bordeaux, France
Hôpital Saint André
Bordeaux, France
Hôpital Henri Mondor
Créteil, France
...and 67 more locations