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TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.

NCT00258557 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2013-06-26

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with anti-retroviral medications (referred to as "treatment-naïve" patients).

Conditions

Interventions

DRUG

LPV/RTV

400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks

DRUG

TMC-114/RTV

two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-06-30
Completion
2012-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Costa Rica
  • Denmark
  • France
  • Germany
  • Greece
  • Guatemala
  • Malaysia
  • Mexico
  • Panama
  • Puerto Rico
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00258557 on ClinicalTrials.gov