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TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants

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ClinicalTrials.gov Identifier: NCT00980538
Recruitment Status : Active, not recruiting
First Posted : September 21, 2009
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

Brief Summary:
The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source [example, access program or government program]), or local standard of care, as appropriate.

Condition or disease Intervention/treatment Phase
HIV Infections HIV-1 Drug: Etravirine Phase 3

Detailed Description:

This is open label continued access trial for HIV-1 infected children/adolescents who have completed treatment in clinical (parent) trial with etravirine (ETR) sponsored by/in collaboration with Janssen Research & Development and who continue to benefit from use of ETR. At baseline visit, eligibility criteria will be checked. If eligibility criteria are met, participants will either continue on ETR dose they received in previous ETR (parent) trial or on adjusted dose if required by investigator.ETR dose adjustment will be based on weight using dosing guidelines. Assessment visits are recommended every 3 months (pediatric) and 6 months (adults). For most of participant, their next visit will be final visit with data collection. New participants entering study, will have baseline visit without data collection. Thereafter visits and assessments will be performed per local standard of care and documented in the participant's medical records only. Investigators will continue to report SAEs possibly related to ETR and pregnancies to sponsor using regular reporting. Treatment will be continued until: investigator determines that participant no longer benefits from ETR treatment (e.g based on viral load); treatment limiting toxicity; loss to follow-up; consent withdrawal; pregnancy; program termination by Sponsor; ETR-based treatment regimen becomes commercially available for participant's use, and is reimbursed, or accessed by another source (e.g access/government program) in region participant is living, or participants switched to local standard of care, as appropriate. Adult participants will receive ETR 200mg BID.Pediatric participants will receive ETR, doses as received in previous ETR(parent) trial, with weight based dose adjustment if necessary.

10 to <20kg:100mg BID (4*25mg or 1 tablet 100mg) 20 to <25kg:125mg BID (5*25mg or 1 tablet 100mg+1 tablet 25mg) 25 to <30kg:150mg BID (6*25mg or 1 tablet 100mg+2 tablets 25mg) >= 30kg:200mg BID (8*25mg or 2*100mg)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects
Actual Study Start Date : December 9, 2009
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : October 31, 2031

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Etravirine
Etravirine Dosed by weight up to a maximum dose of 200 milligram (mg) bid until switched to an etravirine (ETR)-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.
Drug: Etravirine
Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety until ETR-Based Treatment Regimen is Commercially Available [ Time Frame: Up to 14 years ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment will continue until one of the following criteria is met: participant no longer benefits from ETR treatment, toxicity, loss to follow up, etravirine becomes commercially available for participants' use.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who meet all of the following criteria are eligible for this trial: Documented HIV-1 infection
  • Male or female participants, aged 2 years and older
  • Successfully completed a clinical (parent) pediatric trial with ETR sponsored by or in collaboration with Janssen Research & Development, and continues to receive benefit from the use of ETR
  • Participant (where appropriate, depending on age) and their parent(s) or legal representative(s) have signed the Informed Consent Form (ICF)/Assent voluntarily
  • Children will be informed about the program and asked to give assent (where appropriate, depending on age)
  • Negative urine pregnancy test for females of childbearing potential

Exclusion Criteria:

  • Participants meeting one or more of the following criteria cannot be selected: Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the participant's safety or adherence to treatment with ETR
  • Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the participant's safety during treatment with ETR
  • Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR
  • Pregnant or breastfeeding
  • Non-vasectomized heterosexually active boys not using safe and effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication)
  • Girls, who are sexually active and able to become pregnant, not using safe and effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication)

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): NCT00980538


Locations
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United States, California
Los Angeles, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, New York
New York, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Argentina
Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Argentina
Brazil
Belo Horizonte, Brazil
Riberao Preto, Brazil
Rio de Janeiro, Brazil
Canada, Quebec
Montreal, Quebec, Canada
France
Lyon Cedex 08, France
Paris, France
Panama
Panama City, Panama
Puerto Rico
Rio Piedras, Puerto Rico
Romania
Bucuresti, Romania
South Africa
Bloemfontein, South Africa
Boksburg, South Africa
Cape Town, South Africa
Dundee, South Africa
Durban N/a, South Africa
Durban, South Africa
George, South Africa
Johannesburg, South Africa
Newtown, South Africa
Pretoria N/a, South Africa
Pretoria, South Africa
Spain
Esplugues De Llobregat, Spain
Madrid, Spain
Sevilla, Spain
Thailand
Bangkok, Thailand
Khon Kaen, Thailand
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
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Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
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Responsible Party: Janssen Sciences Ireland UC
ClinicalTrials.gov Identifier: NCT00980538    
Other Study ID Numbers: CR016408
TMC125-TID35-C239 ( Other Identifier: Janssen Sciences Ireland UC )
2009-013126-16 ( EudraCT Number )
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Sciences Ireland UC:
TMC125-TiDP35-C239
TMC125-C239
TMC125
HIV
Etravirine
Intelence
IntelenceTM
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Etravirine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents