NCT01066962

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	darunavir/ritonavir QD + raltegravir BID	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)
DRUG	darunavir/r QD + tenofovir/emtricitabine QD (fixed dose combination)	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)

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2010-02-10
• Last updated: 2013-11-06

Locations

77 sites across 15 countries: Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom