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

ANRS, Emerging Infectious Diseases

Status and phase

Completed

Phase 3

Conditions

HIV Infections

Treatments

Drug: darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)

Drug: darunavir/ritonavir QD + raltegravir BID

Study type

Interventional

Funder types

Other

Identifiers

NCT01066962

2009-015113-44 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

800 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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