NCT00711009

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

Conditions

• Human Immunodeficiency Virus Infection

Interventions

Type	Name	Description
DRUG	lopinavir/ritonavir (LPV/r)	LPV/r 400/100 mg BID
DRUG	emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)	FTC/TDF 200/300 mg QD
DRUG	raltegravir (RAL)	RAL 400 mg BID

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-11-01
• Completion: 2010-10-01
• First posted: 2008-07-08
• Last updated: 2012-02-14
• Results posted: 2011-02-02

Locations

37 sites across 7 countries: United States, Canada, France, Italy, Poland, Puerto Rico, Spain