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.

June 25, 2013 updated by: Tibotec Pharmaceuticals, Ireland

Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, controlled, open-label trial to investigate the antiviral activity, tolerability and safety of TMC114/r) versus lpv/rtv in treatment-naive HIV-1 infected patients. Six hundred sixty treatment-naïve HIV-1 infected patients will be randomized in a 1:1 ratio to either 800/100 mg of TMC114/r once daily, or a total daily dose of 800/200 mg of lpv/rtv. All patients will take TMC114/r or lpv/rtv in combination with an NRTI background of Truvada (a combination pill of tenofovir and emtricitabine, "TDF/FTC"). The trial will consist of a screening period of approximately 14 to 28 days and a 96-week treatment period, followed by a 4-week follow-up period. The anti HIV-1 therapy initiated at baseline cannot be changed until the end of the treatment period. After the end of the treatment period (maximum of 96 weeks), patients will be followed for an additional 4 weeks to follow-up on any adverse events or laboratory abnormalities until resolution. Patients who fail either virologically or due to intolerance from the TMC114/r or lpv/rtv therapy, as judged by the investigator, or who meet one of the withdrawal criteria will be withdrawn from the trial and may have the opportunity to participate in the rollover phase of the trial.

The primary efficacy parameter is virologic response defined as a confirmed viral load < 50 copies/mL at Week 48 the objective of this study is to establish non-inferiority of TMC114/r versus lpv/rtv in terms of virologic response at Week 48 using a non-inferiority margin of 12%. To test this hypothesis, a two-sided 95% confidence interval (CI) of the difference in response rate between TMC114/r and lpv/rtv will be derived: If the lower bound of the CI exceeds -12%, non-inferiority will be concluded. Patients will take oral doses for up to 96 weeks of either 800/100mg of TMC114/r 1x/day or 800/200mg of lpv/rtv once daily, each in combination with TDF/FTC. (The 400/100 mg 2x/day dose of lpv/rtv will be used where the 1x/day use of lpv/rtv is not approved).

Study Type

Interventional

Enrollment (Actual)

692

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
      • Mar Del Plata N/A, Argentina
      • Neuquen, Argentina
      • Brisbane, Australia
      • Darlinghurst, Australia
      • Surry Hills, Australia
      • Westmead N/A, Australia
      • Wien, Austria
      • Brussels, Belgium
      • Gent, Belgium
      • Leuven, Belgium
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Providencia, Chile
      • Santiago, Chile
      • Costa Rica, Costa Rica
      • San Jose, Costa Rica
      • Aalborg, Denmark
      • Copenhagen Ø, Denmark
      • Hvidovre, Denmark
      • Bobigny, France
      • Lyon, France
      • Nice, France
      • Orleans Cedex 2, France
      • Paris, France
      • Paris Cedex 12, France
      • Berlin, Germany
      • Erlangen, Germany
      • Freiburg, Germany
      • Hamburg, Germany
      • Köln, Germany
      • Mannheim, Germany
      • Munich, Germany
      • München, Germany
      • Athens, Greece
      • Guatemala, Guatemala
      • Sungai Buloh, Malaysia
      • Ciudad De Mexico, Mexico
      • Del Tlalpan, Mexico
      • Guadalajara N/A, Mexico
      • Mex Ctity, Mexico
      • Panama, Panama
      • San Juan, Puerto Rico
      • Kazan, Russian Federation
      • Krasnodar, Russian Federation
      • Moscow N/A, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Sint Petersburg, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • Volgograd, Russian Federation
      • Voronezh, Russian Federation
      • Singapore, Singapore
      • Cape Town, South Africa
      • Dundee, South Africa
      • Johannesburg, South Africa
      • Pretoria, South Africa
      • Barcelona, Spain
      • Barcelona N/A, Spain
      • Zurich N/A, Switzerland
      • Taipei, Taiwan
      • Tiachung, Taiwan
      • Bangkok, Thailand
      • Chiang Mai, Thailand
      • Khon Kaen, Thailand
      • Brighton, United Kingdom
      • London, United Kingdom
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Sacramento, California, United States
      • San Francisco, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Fort Lauderdale, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Miami Beach, Florida, United States
      • Orlando, Florida, United States
      • Safety Harbor, Florida, United States
      • Tampa, Florida, United States
      • Vero Beach, Florida, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Brooklyn, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Texas
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with documented HIV-1 infection
  • Screening plasma HIV-1 RNA >= 5000 copies/mL
  • Patients qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines
  • Patients who can comply with the protocol requirements
  • General medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.

Exclusion Criteria:

  • Presence of any currently active AIDS defining illness or receiving treatment for primary HIV infection
  • Life expectancy of less than 6 months
  • Previous or current use of antiretroviral medications (ARVs) for the treatment of HIV-infection or hepatitis B infection with anti-HIV activity
  • Female -patients who are pregnant or breast-feeding, or are of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
  • -patients with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading, or a calculated creatinine clearance (CLCr) < 70 mL/min

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 002
TMC-114/RTV two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
Active Comparator: 001
LPV/RTV 400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks
400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment
Time Frame: 192 weeks
192 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

November 22, 2005

First Submitted That Met QC Criteria

November 22, 2005

First Posted (Estimate)

November 24, 2005

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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