A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01266902
First received: December 23, 2010
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
HIV-1 Infection
Drug: Rilpivirine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen R&D Ireland:

Primary Outcome Measures:
  • The number of participants affected by an adverse event [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
  • Any Division of AIDS (DAIDS) grade 3/4 rash [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HIV RNA levels [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • CD4+ cell count [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 488
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rilpivirine
Rilpivirine 25 mg once daily
Drug: Rilpivirine
25 mg once daily

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266902

  Hide Study Locations
Locations
United States, California
Beverly Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Sacramento, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Miami, Florida, United States
Miami Beach, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, New York
Albany, New York, United States
Bronx, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Argentina
Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Cordoba, Argentina
Guernica, Argentina
Rosario, Argentina
Australia
Darlinghurst, Australia
Melbourne, Australia
Perth, Australia
Surry Hills, Australia
Victoria, Australia
Austria
Vienna, Austria
Wien, Austria
Belgium
Antwerpen, Belgium
Brussels, Belgium
Bruxelles, Belgium
Gent, Belgium
Leuven, Belgium
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Montreal N/A, Quebec, Canada
Chile
Santiago, Chile
China
Beijing, China
Guangzhou, China
Shanghai, China
Denmark
Copenhagen, Denmark
Hvidovre N/A, Denmark
Odense N/A, Denmark
France
Clamart, France
Lyon, France
Nantes, France
Paris, France
Paris Cedex 10, France
Paris Cedex 12, France
Paris Cedex 18, France
Tourcoing, France
Germany
Berlin, Germany
Essen, Germany
Frankfurt, Germany
Hamburg, Germany
Hannover, Germany
Köln, Germany
Netherlands
Rotterdam, Netherlands
Puerto Rico
San Juan, Puerto Rico
Romania
Bucuresti, Romania
Iasi, Romania
Russian Federation
Kazan, Russian Federation
Krasnodar, Russian Federation
Moscow N/A, Russian Federation
Saint-Petersburg, Russian Federation
Smolensk, Russian Federation
St Petersburg, Russian Federation
Volgograd, Russian Federation
Voronezh, Russian Federation
South Africa
Bloemfontein, South Africa
Dundee, South Africa
Durban, South Africa
Johannesburg, South Africa
Johannesburg Gauteng, South Africa
Pretoria, South Africa
Westdene Johannesburg Gauteng, South Africa
Spain
Alicante, Spain
Barcelona, Spain
Elche, Spain
Madrid, Spain
Sweden
Stockholm, Sweden
Taiwan
Kaohsiung County, Taiwan
Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Khon Kaen, Thailand
United Kingdom
Brighton, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  More Information

No publications provided

Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01266902     History of Changes
Other Study ID Numbers: CR017434, TMC278-TiDP6-C222
Study First Received: December 23, 2010
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration
Ireland: Irish Agriculture and Food Development Authority
Canada: Health Canada
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Janssen R&D Ireland:
HIV-1 Infection
HIV-1
HIV
TMC278-TiDP6-C222
TMC278-C222
TMC278
Rilpivirine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014