Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01266902
Registration number
NCT01266902
Ethics application status
Date submitted
23/12/2010
Date registered
24/12/2010
Date last updated
4/03/2021
Titles & IDs
Public title
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
Query!
Scientific title
An Open-label Trial With TMC278 25 mg q.d. in Combination With a Background Regimen Containing 2 N(t)RTI's in HIV-1 Infected Subjects Who Participated in TMC278 Clinical Trials and Were Still Benefitting From Treatment With TMC278
Query!
Secondary ID [1]
0
0
TMC278-TiDP6-C222
Query!
Secondary ID [2]
0
0
CR017434
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Rilpivirine
Experimental: Rilpivirine - Rilpivirine 25 mg once daily
Treatment: Drugs: Rilpivirine
25 mg once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events (AEs)
Query!
Assessment method [1]
0
0
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Query!
Timepoint [1]
0
0
Up to 7 years
Query!
Primary outcome [2]
0
0
Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality
Query!
Assessment method [2]
0
0
Number of participants with grade 3/4 events of rash irrespective of causality were assessed. A grade 3 rash defined as diffuse macular, maculopapular or morbilliform rash with vesicles or limited number of bullae or; rash with superficial ulcerations of mucous membranes limited to 1 anatomical site or; rash with at least one of the following: elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) more than 2\*baseline value and at least 5 times upper limit of normal; fever greater than (\>) 38 degree celsius or 100 degree fahrenheit; eosinophils \> 1000/millimeter (mm)\^3; serum sickness-like reaction. A grade 4 rash defined as the following: extensive or generalized bullous lesions or; Stevens-Johnsons Syndrome (SJS) or ulceration of mucous membrane involving 2 or more distinct mucosal sites or toxic epidermal necrolysis.
Query!
Timepoint [2]
0
0
Up to 7 years
Query!
Secondary outcome [1]
0
0
Time to Virologic Rebound
Query!
Assessment method [1]
0
0
Time to virologic rebound was time to (first) human immunodeficiency virus type1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (\>=) 50 or \>=200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Query!
Timepoint [1]
0
0
Up to Week 360
Query!
Secondary outcome [2]
0
0
Time To Treatment Failure
Query!
Assessment method [2]
0
0
Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA \>= 50 or \>= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
Query!
Timepoint [2]
0
0
Up to Week 360
Query!
Secondary outcome [3]
0
0
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336
Query!
Assessment method [3]
0
0
The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach.
Query!
Timepoint [3]
0
0
Baseline up to weeks 96, 192, 288, 336
Query!
Secondary outcome [4]
0
0
Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336
Query!
Assessment method [4]
0
0
Change from baseline in CD4+ cell count were reported for NC=F approach (participants who discontinued because RPV became commercially available or could be accessed through another source or because the participants switched to other local \[RPV-based\] treatment options or local standard of care, were censored at that time; other participants after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach).
Query!
Timepoint [4]
0
0
Baseline up to weeks 96, 192, 288, 336
Query!
Secondary outcome [5]
0
0
Number of Participants With Serious Adverse Events (SAEs)
Query!
Assessment method [5]
0
0
A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect.
Query!
Timepoint [5]
0
0
Up to 7 years
Query!
Secondary outcome [6]
0
0
Number of Participants With AEs Related to Rilpivirine (RPV)
Query!
Assessment method [6]
0
0
Number of participants with AEs related to RPV were assessed. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
Query!
Timepoint [6]
0
0
Up to 7 years
Query!
Eligibility
Key inclusion criteria
* Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.
* Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.
* Patient can comply with the current protocol requirements.
* The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Use of disallowed concomitant therapy.
* Females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of TMC278).
* Non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
482
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Darlinghurst
Query!
Recruitment hospital [2]
0
0
- Melbourne
Query!
Recruitment hospital [3]
0
0
- Perth
Query!
Recruitment hospital [4]
0
0
- Surry Hills
Query!
Recruitment hospital [5]
0
0
- Victoria
Query!
Recruitment postcode(s) [1]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
- Melbourne
Query!
Recruitment postcode(s) [3]
0
0
- Perth
Query!
Recruitment postcode(s) [4]
0
0
- Surry Hills
Query!
Recruitment postcode(s) [5]
0
0
- Victoria
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New York
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oregon
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Washington
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Wisconsin
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Cordoba
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Guernica
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Rosario
Query!
Country [19]
0
0
Austria
Query!
State/province [19]
0
0
Vienna
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
Wien
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Antwerpen
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Brussels
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Bruxelles
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Gent
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Leuven
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
British Columbia
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Manitoba
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Ontario
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Quebec
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Montreal N/a
Query!
Country [31]
0
0
Chile
Query!
State/province [31]
0
0
Santiago
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Beijing
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Guangzhou
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Shanghai
Query!
Country [35]
0
0
Denmark
Query!
State/province [35]
0
0
Copenhagen
Query!
Country [36]
0
0
Denmark
Query!
State/province [36]
0
0
Hvidovre N/a
Query!
Country [37]
0
0
Denmark
Query!
State/province [37]
0
0
Odense N/a
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Clamart
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Lyon
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Nantes
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Paris Cedex 10
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Paris Cedex 12
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Paris Cedex 18
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Paris
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Tourcoing
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Berlin
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Essen
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Frankfurt
Query!
Country [49]
0
0
Germany
Query!
State/province [49]
0
0
Hamburg
Query!
Country [50]
0
0
Germany
Query!
State/province [50]
0
0
Hannover
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Köln
Query!
Country [52]
0
0
Netherlands
Query!
State/province [52]
0
0
Rotterdam
Query!
Country [53]
0
0
Puerto Rico
Query!
State/province [53]
0
0
San Juan
Query!
Country [54]
0
0
Romania
Query!
State/province [54]
0
0
Bucuresti
Query!
Country [55]
0
0
Romania
Query!
State/province [55]
0
0
Iasi
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Kazan
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
Krasnodar
Query!
Country [58]
0
0
Russian Federation
Query!
State/province [58]
0
0
Moscow N/a
Query!
Country [59]
0
0
Russian Federation
Query!
State/province [59]
0
0
Saint-Petersburg
Query!
Country [60]
0
0
Russian Federation
Query!
State/province [60]
0
0
Smolensk
Query!
Country [61]
0
0
Russian Federation
Query!
State/province [61]
0
0
St Petersburg
Query!
Country [62]
0
0
Russian Federation
Query!
State/province [62]
0
0
Volgograd
Query!
Country [63]
0
0
Russian Federation
Query!
State/province [63]
0
0
Voronezh
Query!
Country [64]
0
0
South Africa
Query!
State/province [64]
0
0
Bloemfontein
Query!
Country [65]
0
0
South Africa
Query!
State/province [65]
0
0
Dundee
Query!
Country [66]
0
0
South Africa
Query!
State/province [66]
0
0
Durban
Query!
Country [67]
0
0
South Africa
Query!
State/province [67]
0
0
Johannesburg Gauteng
Query!
Country [68]
0
0
South Africa
Query!
State/province [68]
0
0
Johannesburg
Query!
Country [69]
0
0
South Africa
Query!
State/province [69]
0
0
Pretoria
Query!
Country [70]
0
0
South Africa
Query!
State/province [70]
0
0
Westdene Johannesburg Gauteng
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Alicante
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Barcelona
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Elche
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Madrid
Query!
Country [75]
0
0
Sweden
Query!
State/province [75]
0
0
Stockholm
Query!
Country [76]
0
0
Taiwan
Query!
State/province [76]
0
0
Kaohsiung County
Query!
Country [77]
0
0
Thailand
Query!
State/province [77]
0
0
Bangkok
Query!
Country [78]
0
0
Thailand
Query!
State/province [78]
0
0
Chiang Mai
Query!
Country [79]
0
0
Thailand
Query!
State/province [79]
0
0
Khon Kaen
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
Brighton
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
London
Query!
Country [82]
0
0
United Kingdom
Query!
State/province [82]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen R&D Ireland
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01266902
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen R&D Ireland Clinical Trial
Query!
Address
0
0
Janssen R&D Ireland
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/02/NCT01266902/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/02/NCT01266902/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01266902
Download to PDF