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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00258557




Registration number
NCT00258557
Ethics application status
Date submitted
22/11/2005
Date registered
24/11/2005
Date last updated
26/06/2013

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 0 0
TMC114-C211
Secondary ID [2] 0 0
CR002800
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LPV/RTV
Treatment: Drugs - TMC-114/RTV

Experimental: 002 - TMC-114/RTV 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


Treatment: Drugs: LPV/RTV
400/100 mg twice daily or 800/200 mg daily depending on the country for max. 192 weeks

Treatment: Drugs: TMC-114/RTV
two 400 mg tablets of TMC114 + one 100 mg capsule of RTV daily for max. 192 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment
Timepoint [1] 0 0
192 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
692
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Surry Hills
Recruitment hospital [4] 0 0
- Westmead N/A
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Surry Hills
Recruitment postcode(s) [4] 0 0
- Westmead N/A
Recruitment outside Australia
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United States of America
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Arizona
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California
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District of Columbia
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Florida
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Maryland
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Massachusetts
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Nevada
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New York
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North Carolina
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Pennsylvania
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South Carolina
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Texas
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Argentina
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Buenos Aires
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Argentina
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Mar Del Plata N/A
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Argentina
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Neuquen
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Providencia
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Chile
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Santiago
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Costa Rica
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Costa Rica
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Costa Rica
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San Jose
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Denmark
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Aalborg
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Denmark
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Copenhagen Ø
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Denmark
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Hvidovre
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France
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Bobigny
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France
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Lyon
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France
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Nice
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France
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Orleans Cedex 2
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France
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Paris Cedex 12
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France
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Paris
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Freiburg
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Hamburg
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Köln
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Mannheim
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Munich
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München
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Greece
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Athens
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Guatemala
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Guatemala
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Malaysia
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Sungai Buloh
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Mexico
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Ciudad De Mexico
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Mexico
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Del Tlalpan
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Mexico
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Guadalajara N/A
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Mexico
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Mex Ctity
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Panama
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Panama
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Puerto Rico
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San Juan
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Russian Federation
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Kazan
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Russian Federation
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Krasnodar
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Moscow N/A
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Russian Federation
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Saint-Petersburg
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Sint Petersburg
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Smolensk
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St Petersburg
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Russian Federation
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Volgograd
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Russian Federation
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Voronezh
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Singapore
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Singapore
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South Africa
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Cape Town
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South Africa
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Dundee
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Spain
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Barcelona N/A
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Spain
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Barcelona
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Switzerland
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Zurich N/A
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Taiwan
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Taipei
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Taiwan
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Tiachung
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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United Kingdom
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Brighton
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tibotec Pharmaceuticals, Ireland
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT00258557
Trial related presentations / publications
Mills AM, Nelson M, Jayaweera D, Ruxrungtham K, Cassetti I, Girard PM, Workman C, Dierynck I, Sekar V, Abeele CV, Lavreys L. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009 Aug 24;23(13):1679-88. doi: 10.1097/QAD.0b013e32832d7350.
Orkin C, DeJesus E, Khanlou H, Stoehr A, Supparatpinyo K, Lathouwers E, Lefebvre E, Opsomer M, Van de Casteele T, Tomaka F. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naive patients in the ARTEMIS trial. HIV Med. 2013 Jan;14(1):49-59. doi: 10.1111/j.1468-1293.2012.01060.x. Epub 2012 Oct 23.
Public notes

Contacts
Principal investigator
Name 0 0
Tibotec Pharmaceuticals Clinical Trial
Address 0 0
Tibotec Pharmaceutical Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00258557