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

NCT ID: NCT01266902

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 482 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2020-02-29

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.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rilpivirine

Rilpivirine 25 mg once daily

Group Type: EXPERIMENTAL

Rilpivirine

Intervention Type: DRUG

25 mg once daily

Interventions

Rilpivirine

25 mg once daily

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen R&D Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen R&D Ireland Clinical Trial

Role: STUDY_DIRECTOR

Janssen R&D Ireland

Locations

Beverly Hills, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Newport Beach, California, United States

Sacramento, California, United States

Washington D.C., District of Columbia, United States

Miami, Florida, United States

Miami Beach, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Minneapolis, Minnesota, United States

Albany, New York, United States

New York, New York, United States

Rochester, New York, United States

The Bronx, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

Longview, Texas, United States

Seattle, Washington, United States

Milwaukee, Wisconsin, United States

Buenos Aires, , Argentina

Ciudad Autonoma Buenos Aires, , Argentina

Córdoba, , Argentina

Guernica, , Argentina

Rosario, , Argentina

Darlinghurst, , Australia

Melbourne, , Australia

Perth, , Australia

Surry Hills, , Australia

Victoria, , Australia

Vienna, , Austria

Antwerp, , Belgium

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, , Canada

Santiago, , Chile

Beijing, , China

Guangzhou, , China

Shanghai, , China

Copenhagen, , Denmark

Hvidovre, , Denmark

Odense, , Denmark

Clamart, , France

Lyon, , France

Nantes, , France

Paris, , France

Tourcoing, , France

Berlin, , Germany

Cologne, , Germany

Essen, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Hanover, , Germany

Rotterdam, , Netherlands

San Juan, , Puerto Rico

Bucharest, , Romania

Iași, , Romania

Kazan', , Russia

Krasnodar, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Volgograd, , Russia

Voronezh, , Russia

Bloemfontein, , South Africa

Dundee, , South Africa

Durban, , South Africa

Johannesburg, , South Africa

Johannesburg Gauteng, , South Africa

Pretoria, , South Africa

Westdene Johannesburg Gauteng, , South Africa

Alicante, , Spain

Barcelona, , Spain

Elche, , Spain

Madrid, , Spain

Stockholm, , Sweden

Kaohsiung County, , Taiwan

Bangkok, , Thailand

Chiang Mai, , Thailand

Khon Kaen, , Thailand

Brighton, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Canada; Chile; China; Denmark; France; Germany; Netherlands; Puerto Rico; Romania; Russia; South Africa; Spain; Sweden; Taiwan; Thailand; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TMC278-TiDP6-C222

Identifier Type: OTHER

Identifier Source: secondary_id

2010-021209-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR017434

Identifier Type: -

Identifier Source: org_study_id