Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming weeks in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT00359021
Ethics application status
Date submitted
28/07/2006
Date registered
28/07/2006
Date last updated
6/05/2014

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 - The table below provides the number of participants who experienced Serious Adverse Events (SAEs) and Other Adverse Events (except SAEs) that started or worsened in severity during the overall TMC125-C217 treatment period. The duration of treatment ranged per patient from 1 week to 180 weeks, with a median of 62 weeks.
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 - The table below shows the percentage of participants with virologic suppression (< 50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available over time (ie, at Weeks 24, 48, and 96).
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) - In the table below, the total number of participants analyzed in the Duet Placebo and Duet TMC125 groups, respectively at each time point were: Baseline (256;247 participants), Week 24 (251;240 participants), Week 48 (235;192 participants), and Week 96 (123;69 participants).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Cordoba
Country [19] 0 0
Argentina
State/province [19] 0 0
Florencio Varela
Country [20] 0 0
Argentina
State/province [20] 0 0
Neuquen
Country [21] 0 0
Belgium
State/province [21] 0 0
Antwerpen
Country [22] 0 0
Belgium
State/province [22] 0 0
Liege
Country [23] 0 0
Brazil
State/province [23] 0 0
Curitiba
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio De Janeiro
Country [25] 0 0
Brazil
State/province [25] 0 0
Salvador
Country [26] 0 0
Brazil
State/province [26] 0 0
Sao Paulo
Country [27] 0 0
Canada
State/province [27] 0 0
Alberta
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Toronto
Country [31] 0 0
Chile
State/province [31] 0 0
Providencia
Country [32] 0 0
Chile
State/province [32] 0 0
Santiago
Country [33] 0 0
France
State/province [33] 0 0
Bordeaux Cedex
Country [34] 0 0
France
State/province [34] 0 0
Bordeaux N/A
Country [35] 0 0
France
State/province [35] 0 0
Le Kremlin Bicetre
Country [36] 0 0
France
State/province [36] 0 0
Lyon
Country [37] 0 0
France
State/province [37] 0 0
Marseille Cedex 09
Country [38] 0 0
France
State/province [38] 0 0
Paris Cedex 10
Country [39] 0 0
France
State/province [39] 0 0
Paris Cedex 12
Country [40] 0 0
France
State/province [40] 0 0
Paris Cedex 15
Country [41] 0 0
France
State/province [41] 0 0
Paris, 75
Country [42] 0 0
France
State/province [42] 0 0
Paris
Country [43] 0 0
France
State/province [43] 0 0
Rennes
Country [44] 0 0
France
State/province [44] 0 0
Toulouse
Country [45] 0 0
France
State/province [45] 0 0
Tourcoing
Country [46] 0 0
France
State/province [46] 0 0
Villejuif N/A
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Essen
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Mannheim
Country [51] 0 0
Germany
State/province [51] 0 0
München
Country [52] 0 0
Mexico
State/province [52] 0 0
Ciudad De Mexico
Country [53] 0 0
Mexico
State/province [53] 0 0
Mex Ctity
Country [54] 0 0
Panama
State/province [54] 0 0
Panama
Country [55] 0 0
Puerto Rico
State/province [55] 0 0
San Juan
Country [56] 0 0
Spain
State/province [56] 0 0
Barcelona N/A
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Madrid
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Thailand
State/province [60] 0 0
Bangkok
Country [61] 0 0
Thailand
State/province [61] 0 0
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/show/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