Clinical trial NCT01266902: A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1 Infection
Keywords: HIV-1 Infection
HIV-1
HIV
TMC278-TiDP6-C222
TMC278-C222
TMC278
Rilpivirine
Lead sponsor: Janssen R&D Ireland
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is a Phase III, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to TMC278 to HIV-1 infected patients who were randomized (the study drug is assigned by chance) and treated with TMC278 in the Phase IIb (TMC278-C204 \[C204\]) or Phase III trials (i.e., TMC278-TiDP6-C209 \[C209\] or TMC278-TiDP6-C215 \[C215\]) and who continue to benefit from their antiretroviral treatment, according to the investigator. In addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of TMC278 25 mg once daily (q.d.) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. Approximately 750 HIV-1 infected individuals are expected to participate in this trial. The duration of participation in the study for an individual participant will be 2 to 3 years. The final/withdrawal visit of the Phase IIb or Phase III trials will be the first visit of this trial. Safety and tolerability will be evaluated throughout the trial. Visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. Oral tablets of TMC278 25 mg once daily (q.d.) should be administered together with a meal.

Eligibility criteria: 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.

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).

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 7 years
measure: Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality
timeFrame: Up to 7 years
Secondary outcomes:
measure: Time to Virologic Rebound
timeFrame: Up to Week 360
measure: Time To Treatment Failure
timeFrame: Up to Week 360
measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336
timeFrame: Baseline up to weeks 96, 192, 288, 336
measure: Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336
timeFrame: Baseline up to weeks 96, 192, 288, 336
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 7 years
measure: Number of Participants With AEs Related to Rilpivirine (RPV)
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Guernica
country: Argentina
city: Rosario
country: Argentina
city: Darlinghurst
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Surry Hills
country: Australia
city: Victoria
country: Australia
city: Vienna
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal N/a
country: Canada
city: Santiago
country: Chile
city: Beijing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Copenhagen
country: Denmark
city: Hvidovre N/a
country: Denmark
city: Odense N/a
country: Denmark
city: Clamart
country: France
city: Lyon
country: France
city: Nantes
country: France
city: Paris Cedex 10
country: France
city: Paris Cedex 12
country: France
city: Paris Cedex 18
country: France
city: Paris
country: France
city: Tourcoing
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Köln
country: Germany
city: Rotterdam
country: Netherlands
city: San Juan
country: Puerto Rico
city: Bucuresti
country: Romania
city: Iasi
country: Romania
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow N/a
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Bloemfontein
country: South Africa
city: Dundee
country: South Africa
city: Durban
country: South Africa
city: Johannesburg Gauteng
country: South Africa
city: Johannesburg
country: South Africa
city: Pretoria
country: South Africa
city: Westdene Johannesburg Gauteng
country: South Africa
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Elche
country: Spain
city: Madrid
country: Spain
city: Stockholm
country: Sweden
city: Kaohsiung County
country: Taiwan
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Khon Kaen
country: Thailand
city: Brighton
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Janssen R&D Ireland
name: Janssen R&D Ireland Clinical Trial
role: STUDY_DIRECTOR
References: