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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: NEAT - European AIDS Treatment Network
• Treatments: Darunavir; Emtricitabine; Raltegravir Potassium; Ritonavir; Tenofovir

Criteria

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