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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
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
Secondary ID [1] 0 0
TMC278-TiDP6-C222
Secondary ID [2] 0 0
CR017434
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Rilpivirine

Experimental: Rilpivirine - Rilpivirine 25 mg once daily


Treatment: Drugs: Rilpivirine
25 mg once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to 7 years
Primary outcome [2] 0 0
Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [1] 0 0
Time to Virologic Rebound
Timepoint [1] 0 0
Up to Week 360
Secondary outcome [2] 0 0
Time To Treatment Failure
Timepoint [2] 0 0
Up to Week 360
Secondary outcome [3] 0 0
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336
Timepoint [3] 0 0
Baseline up to weeks 96, 192, 288, 336
Secondary outcome [4] 0 0
Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336
Timepoint [4] 0 0
Baseline up to weeks 96, 192, 288, 336
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Up to 7 years
Secondary outcome [6] 0 0
Number of Participants With AEs Related to Rilpivirine (RPV)
Timepoint [6] 0 0
Up to 7 years

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.
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.
* 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/02/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2020
Sample size
Target
Accrual to date
Final
482
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 hospital [4] 0 0
- Surry Hills
Recruitment hospital [5] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Surry Hills
Recruitment postcode(s) [5] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
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United States of America
State/province [3] 0 0
Florida
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United States of America
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Illinois
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United States of America
State/province [5] 0 0
Massachusetts
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United States of America
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Minnesota
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United States of America
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New York
Country [8] 0 0
United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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Guernica
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Argentina
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Rosario
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Bruxelles
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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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Manitoba
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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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Montreal N/a
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Chile
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Santiago
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China
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Beijing
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China
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Guangzhou
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China
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Shanghai
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Denmark
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Copenhagen
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Denmark
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Hvidovre N/a
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Denmark
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Odense N/a
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France
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Clamart
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France
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Lyon
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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 Cedex 18
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France
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Paris
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France
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Tourcoing
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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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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Köln
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Netherlands
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Rotterdam
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Iasi
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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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Russian Federation
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Moscow N/a
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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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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South Africa
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Bloemfontein
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South Africa
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Dundee
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South Africa
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Durban
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South Africa
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Johannesburg Gauteng
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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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South Africa
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Westdene Johannesburg Gauteng
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Elche
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Spain
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Madrid
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Sweden
State/province [75] 0 0
Stockholm
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Taiwan
State/province [76] 0 0
Kaohsiung County
Country [77] 0 0
Thailand
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Bangkok
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Thailand
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Chiang Mai
Country [79] 0 0
Thailand
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Khon Kaen
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Brighton
Country [81] 0 0
United Kingdom
State/province [81] 0 0
London
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen R&D Ireland
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01266902
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen R&D Ireland Clinical Trial
Address 0 0
Janssen R&D Ireland
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/NCT01266902