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

Condition(s) targeted: HIV Infections

Intervention: darunavir/ritonavir QD + raltegravir BID (Drug); darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis

Official(s) and/or principal investigator(s):
François Raffi, Professor, Study Chair, Affiliation: Nantes University Hospital

Overall contact:
François Raffi, Email: francois.raffi@wanadoo.fr

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.

Official title: 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)

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to virologic or clinical failure, as the first occurrence of one of six protocol-defined components

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- 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

- 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 mg/dl or INR > 1. 7 or presence of ascites, in the absence of another explanation for the abnormal finding

- CD4 > 500/mm3, except in case of symptomatic HIV disease (defined by conditions

qualifiying for CDC category B or C)

- 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

François Raffi, Email: francois.raffi@wanadoo.fr

University Hospital, Nantes, France; Recruiting
François RAFFI
François Raffi, Principal Investigator

Starting date: August 2010
Last updated: September 15, 2010