NCT01274780

Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Juan A. Arnaiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels. Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be \<4.5 or ≥ 4.5).

Conditions

• HIV-1

Interventions

Type	Name	Description
DRUG	Darunavir / Ritonavir + Tenofovir / Emtricitabine	oral, 800/100 mg, qd + oral, 300/200 mg, qd
DRUG	Atazanavir / Ritonavir + Tenofovir / Emtricitabine	oral, 300/100 mg, qd + oral, 300/200 mg, qd

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-05-01
• Completion: 2014-01-01
• First posted: 2011-01-12
• Last updated: 2014-12-16

Locations

1 site across 1 country: Spain