HIV Infections
Conditions
Keywords
HIV-infected antiretroviral naïve subjects
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.
Interventions
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)
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components | minimum 2 years |
Countries
Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom