Back to resultsTMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
Primary Purpose
HIV Infections, HIV-1
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Etravirine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring TMC125-TiDP35-C239, TMC125-C239, TMC125, HIV, Etravirine, Intelence, IntelenceTM
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Etravirine
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00980538
First Posted
September 18, 2009
Last Updated
October 10, 2023
Sponsor
Janssen Sciences Ireland UC
1. Study Identification
Unique Protocol Identification Number
NCT00980538
Brief Title
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
Official Title
Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 9, 2009 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
October 31, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Sciences Ireland UC
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV-1
Keywords
TMC125-TiDP35-C239, TMC125-C239, TMC125, HIV, Etravirine, Intelence, IntelenceTM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Etravirine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Etravirine
Intervention Description
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 Measure Information:
Title
Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available
Description
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.
Time Frame
Up to 10 years and 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Sciences Ireland UC Clinical Trial
Organizational Affiliation
Janssen Sciences Ireland UC
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
New York
State/Province
New York
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Buenos Aires
Country
Argentina
City
Ciudad Autonoma De Buenos Aire
Country
Argentina
City
Belo Horizonte
Country
Brazil
City
Ribeirao Preto
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Montreal
State/Province
Quebec
Country
Canada
City
Lyon Cedex 08
Country
France
City
Paris
Country
France
City
Panama City
Country
Panama
City
Rio Piedras
Country
Puerto Rico
City
Bucuresti
Country
Romania
City
Bloemfontein
Country
South Africa
City
Boksburg
Country
South Africa
City
Cape Town
Country
South Africa
City
Dundee
Country
South Africa
City
Durban N/a
Country
South Africa
City
Durban
Country
South Africa
City
George
Country
South Africa
City
Johannesburg
Country
South Africa
City
Newtown
Country
South Africa
City
Pretoria N/a
Country
South Africa
City
Pretoria
Country
South Africa
City
Esplugues De Llobregat
Country
Spain
City
Madrid
Country
Spain
City
Sevilla
Country
Spain
City
Bangkok
Country
Thailand
City
Khon Kaen
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
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