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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00081588




Registration number
NCT00081588
Ethics application status
Date submitted
15/04/2004
Date registered
19/04/2004
Date last updated
20/06/2014

Titles & IDs
Public title
An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
Scientific title
An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
Secondary ID [1] 0 0
TMC114-C215
Secondary ID [2] 0 0
CR006724
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TMC114

Experimental: 001 - TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available


Treatment: Drugs: TMC114
600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary parameter is the confirmed virologic response at Week 24 (a drop in viral load (copies/mL) of at least 1 log10 versus baseline.
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Proportion of patients with a virologic response; with plasma HIV-1 RNA levels < 50 copies/mL; with plasma HIV-1 RNA levels < 400 copies/mL; Time to loss of virologic response over 144 week treatment period; Change in plasma viral load at all time points
Timepoint [1] 0 0
144 weeks

Eligibility
Key inclusion criteria
* Previous participation in the TMC114-C202 or TMC114-C213 trials
* Significant virologic failure during participation in the above trials
* Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
* Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards
* Patient has given informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of disallowed concomitant therapy
* Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
* Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
* Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol
* Patient withdrawing consent from TMC114-C202 or TMC114-C213

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 2
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
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
555
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Melbourne
Recruitment hospital [3] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment outside Australia
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United States of America
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Alabama
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California
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District of Columbia
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Florida
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Georgia
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Illinois
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Massachusetts
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New York
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Ohio
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Pennsylvania
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Texas
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Austria
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Vienna
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Wien
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Belgium
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Brussels
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Belgium
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Brussel
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Belgium
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Gent
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Rio De Janeiro
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Brazil
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Sao Paulo
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Canada
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Canada
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Ontario
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Canada
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Quebec
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France
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Le Kremlin Bicetre
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France
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Montpellier
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France
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Nantes
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France
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Paris Cedex 10
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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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France
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Toulon
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Kÿln
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Germany
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Mannheim
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Germany
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Munich
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Hungary
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Budapest
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Portugal
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Lisboa
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Portugal
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Porto
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Spain
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Barakaldo Vizcaya S/N
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Spain
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Barcelona N/A
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Spain
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Madrid
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United Kingdom
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Edinburgh
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United Kingdom
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London
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United Kingdom
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Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time.
Trial website
https://clinicaltrials.gov/study/NCT00081588
Trial related presentations / publications
Molina JM, Cohen C, Katlama C, Grinsztejn B, Timerman A, Pedro Rde J, Vangeneugden T, Miralles D, Meyer SD, Parys W, Lefebvre E; TMC114-C208 Study Group; TMC114-C215 Study Group. Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3. J Acquir Immune Defic Syndr. 2007 Sep 1;46(1):24-31. doi: 10.1097/QAI.0b013e3181359cfb.
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/NCT00081588