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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00359021




Registration number
NCT00359021
Ethics application status
Date submitted
28/07/2006
Date registered
1/08/2006
Date last updated
16/05/2014

Titles & IDs
Public title
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
Scientific title
An Open-label Trial With TMC125 as Part of an ART Including TMC114/Rtv and an Investigator-selected OBR in HIV-1 Infected Subjects Who Participated in a DUET Phase III Trial (TMC125-C206 or TMC125-C216).
Secondary ID [1] 0 0
TMC125-C217
Secondary ID [2] 0 0
CR002740
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TMC125

Experimental: 001 - TMC125 200 mg twice daily until commercially available


Treatment: Drugs: TMC125
200 mg twice daily until commercially available
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants Experiencing Adverse Events
Timepoint [1] 0 0
1 week to 180 weeks, with a median of 62 weeks
Secondary outcome [1] 0 0
The Percentage of Participants With Virologic Outcomes Over Time
Timepoint [1] 0 0
Weeks 24, 48, and 96
Secondary outcome [2] 0 0
Change in Plasma Viral Load Versus Baseline (ie, Mean Change in log10 Plasma Viral Load From Baseline Over Time)
Timepoint [2] 0 0
Baseline, Week 24, Week 48, and Week 96

Eligibility
Key inclusion criteria
* Patient was previously randomized in a DUET (TMC125-C206 or TMC125-C216) trial and completed at least 24 weeks of treatment
* Patient was virologically failing in a DUET trial.
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
* Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table
* Patients who had to be withdrawn from the DUET (TMC125-C206 or TMC125-C216) trials because of any of the mandatory withdrawal criteria of that trial.

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 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
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
503
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Illinois
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Massachusetts
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New Jersey
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New York
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North Carolina
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Oregon
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Pennsylvania
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Florencio Varela
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Belgium
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Antwerpen
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Belgium
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Liege
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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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Salvador
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Toronto
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Chile
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Providencia
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Chile
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Santiago
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France
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Bordeaux Cedex
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France
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Bordeaux N/A
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France
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Le Kremlin Bicetre
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France
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Lyon
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France
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Marseille Cedex 09
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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 Cedex 15
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France
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Paris, 75
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France
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Paris
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France
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Rennes
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France
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Toulouse
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France
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Tourcoing
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France
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Villejuif N/A
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Germany
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Berlin
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Mannheim
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Germany
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München
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Mexico
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Ciudad De Mexico
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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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Spain
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Barcelona N/A
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Thailand
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Bangkok
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Thailand
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Khon Kaen

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 trial is to evaluate the long-term safety and tolerability of TMC125 200 mg twice daily as part of an antiretroviral therapy including TMC114/rtv and an investigator selected optimized background in HIV-1 infected patients who have participated in a DUET trial (TMC125-C206 or TMC125 C216) and have met the definition of virologic failure at Week 24 or later in these trials.
Trial website
https://clinicaltrials.gov/study/NCT00359021
Trial related presentations / publications
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/NCT00359021