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

NCT01266902 | Completed Phase 3 Results

• 3 other identifiers: CR017434TMC278-TiDP6-C2222010-021209-18
• Study Type: interventional
• Target: 482
• Locations: 20 countries
• Sites: 93

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.

Conditions

HIV-1 Infection

Keywords

HIV-1 Infection; HIV-1; HIV; TMC278-TiDP6-C222; TMC278-C222; TMC278; Rilpivirine

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  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.

  Up to 7 years

• Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality

  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.

  Up to 7 years

Secondary Outcomes (6)

• Time to Virologic Rebound

  Up to Week 360

• Time To Treatment Failure

  Up to Week 360

• Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336

  Baseline up to weeks 96, 192, 288, 336

• Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336

  Baseline up to weeks 96, 192, 288, 336

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 7 years

Study Arms (1)

Rilpivirine

EXPERIMENTAL

Rilpivirine 25 mg once daily

Drug: Rilpivirine

Interventions

Rilpivirine DRUG

25 mg once daily

Rilpivirine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (98)

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Beverly Hills, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Sacramento, California, United States

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

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Albany, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Seattle, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, Argentina

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Ciudad Autonoma Buenos Aires, Argentina

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Córdoba, Argentina

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Guernica, Argentina

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Rosario, Argentina

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Darlinghurst, Australia

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Melbourne, Australia

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Perth, Australia

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Surry Hills, Australia

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Victoria, Australia

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Vienna, Austria

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Antwerp, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Canada

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Santiago, Chile

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Beijing, China

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Guangzhou, China

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Shanghai, China

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Copenhagen, Denmark

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Hvidovre, Denmark

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Odense, Denmark

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Clamart, France

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Lyon, France

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Nantes, France

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Paris, France

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Tourcoing, France

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Berlin, Germany

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Cologne, Germany

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Essen, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Hanover, Germany

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Rotterdam, Netherlands

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San Juan, Puerto Rico

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Bucharest, Romania

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Iași, Romania

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Kazan', Russia

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Krasnodar, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Volgograd, Russia

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Voronezh, Russia

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Bloemfontein, South Africa

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Dundee, South Africa

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Durban, South Africa

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Johannesburg, South Africa

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Johannesburg Gauteng, South Africa

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Pretoria, South Africa

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Westdene Johannesburg Gauteng, South Africa

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Alicante, Spain

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Barcelona, Spain

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Elche, Spain

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Madrid, Spain

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Stockholm, Sweden

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Kaohsiung County, Taiwan

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Bangkok, Thailand

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Chiang Mai, Thailand

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Khon Kaen, Thailand

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Brighton, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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MeSH Terms

Interventions

Rilpivirine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Not all Adverse Events (AEs) were collected; AEs considered related to rilpivirine (RPV), leading to discontinuations, serious adverse events (SAEs), or grade 3/4 events of rash regardless of causality were collected; discontinuation rate was greater than (\>) 90 percent which makes interpretation of results difficult.

Results Point of Contact

• Title: Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen R&D Ireland Clinical Trial

  Janssen R&D Ireland

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: February 1, 2011
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Locations

TH (3); CL (1); DK (3); FR (5); ES (4); CA (6); CN (3); AU (1); BE (4); RO (2); GB (3); US (29); RU (7); NL (1); DE (6); ZA (7); TW (1); PR (1); AR (5); SE (1)