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)

NCT01066962 Phase 3 COMPLETED

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.

Details

Lead sponsor	ANRS, Emerging Infectious Diseases
Phase	Phase 3
Status	COMPLETED
Enrolment	800
Start date	2010-08
Completion	2013-10

Conditions

• HIV Infections

Interventions

• darunavir/ritonavir QD + raltegravir BID
• darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)

Primary outcomes

• 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