CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 206 enrolled
Drug / intervention
lopinavir/ritonavir (LPV/r) +2 moredrug
Likely dose
lopinavir/ritonavir (LPV/r) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00711009
NCT00711009Phase 3Completed
CompareCT.gov

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

Abbott·interventional·Posted Jul 8, 2008·Updated Feb 14, 2012

In Brief

A Phase 3 clinical trial evaluating lopinavir/ritonavir (LPV/r), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), and 1 other intervention for Human Immunodeficiency Virus Infection. Completed, enrolled 206 participants across 37 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus Infection
CountriesCanada, France, Italy, Poland, Puerto Rico, Spain, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 8, 2008
Enrollment StartJul 1, 2008
Primary CompletionNov 1, 2009
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.0 years ago

Interventions

lopinavir/ritonavir (LPV/r)drug

LPV/r 400/100 mg BID

emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)drug

FTC/TDF 200/300 mg QD

raltegravir (RAL)drug

RAL 400 mg BID