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

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

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.

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)

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• Study Director: Janssen Sciences Ireland UC Clinical Trial; Janssen Sciences Ireland UC

More Information

• 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
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

• 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:

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