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

NCT00711009 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2012-02-14

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Thomas J Podsadecki, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-11-30
Completion
2010-10-31

Countries

  • United States
  • Canada
  • France
  • Italy
  • Poland
  • Puerto Rico
  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711009 on ClinicalTrials.gov