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

Phase 4 Completed 180 enrolled Juan A. Arnaiz

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2011-05
Primary completion: 2013-05
Completion: 2014-01

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atazanavir	Other / unclassified	300 mg	Oral
Subject	Darunavir	Small molecule	800 mg	Oral
Background	Ritonavir	Other / unclassified	100 mg	Oral
Background	Tenofovir	Small molecule	300 mg	Oral
Background	emtricitabine	Other / unclassified	200 mg	Oral

Indications

No indication recorded.