NCT00980538

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

Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Janssen Sciences Ireland UC · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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)

Conditions

• HIV Infections
• HIV-1

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-12-09
• Primary completion: 2020-11-25
• Completion: 2026-04-06
• First posted: 2009-09-21
• Last updated: 2026-03-27
• Results posted: 2021-12-21

Locations

29 sites across 11 countries: United States, Argentina, Brazil, Canada, France, Panama, Puerto Rico, Romania, South Africa, Spain, Thailand