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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01266902
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland

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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Rilpivirine Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 482 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : February 2011
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Rilpivirine

Arm Intervention/treatment
Experimental: Rilpivirine
Rilpivirine 25 mg once daily
Drug: Rilpivirine
25 mg once daily




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 7 years ]
    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.

  2. Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality [ Time Frame: Up to 7 years ]
    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.


Secondary Outcome Measures :
  1. Time to Virologic Rebound [ Time Frame: Up to Week 360 ]
    Time to virologic rebound was time to (first) human immunodeficiency virus type1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (>=) 50 or >=200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

  2. Time To Treatment Failure [ Time Frame: Up to Week 360 ]
    Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA >= 50 or >= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

  3. Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336 [ Time Frame: Baseline up to weeks 96, 192, 288, 336 ]
    The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach.

  4. Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336 [ Time Frame: Baseline up to weeks 96, 192, 288, 336 ]
    Change from baseline in CD4+ cell count were reported for NC=F approach (participants who discontinued because RPV became commercially available or could be accessed through another source or because the participants switched to other local [RPV-based] treatment options or local standard of care, were censored at that time; other participants after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach).

  5. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 7 years ]
    A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect.

  6. Number of Participants With AEs Related to Rilpivirine (RPV) [ Time Frame: Up to 7 years ]
    Number of participants with AEs related to RPV were assessed. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266902


Locations
Show Show 104 study locations
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
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Study Director: Janssen R&D Ireland Clinical Trial Janssen R&D Ireland
  Study Documents (Full-Text)

Documents provided by Janssen R&D Ireland:
Study Protocol  [PDF] November 28, 2016
Statistical Analysis Plan  [PDF] March 26, 2018

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Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01266902    
Other Study ID Numbers: CR017434
TMC278-TiDP6-C222 ( Other Identifier: Janssen R&D Ireland )
2010-021209-18 ( EudraCT Number )
First Posted: December 24, 2010    Key Record Dates
Results First Posted: March 4, 2021
Last Update Posted: March 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen R&D Ireland:
HIV-1 Infection
HIV-1
HIV
TMC278-TiDP6-C222
TMC278-C222
TMC278
Rilpivirine
Additional relevant MeSH terms:
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Infections
Rilpivirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents