CompletedPhase 3

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

United States, Argentina, Brazil180 participantsStarted 2009-12-09

Plain-language 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.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 contro…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial was specifically for treatment-experienced HIV-1 patients, can you help me understand whether my own treatment history would have made me a candidate, and what that tells us about which HIV medications might be appropriate for me now?
2This trial was focused on continued access to etravirine while it became commercially available — is etravirine now available as a standard treatment option, and is it something worth considering as part of my regimen?
3The trial's main goal was tracking adverse events and safety rather than measuring how well etravirine works — what does that tell us about what was already known about its effectiveness, and how confident are you in its safety profile based on the full body of evidence?
4Since this trial is now completed, are there published results about the adverse events participants experienced that we should review together before considering etravirine as part of my treatment plan?
5Given that etravirine is designed for people whose HIV has already developed resistance to other treatments, should we be testing my virus for resistance patterns now, so we have that information ready if my current regimen ever stops working?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available

Timeframe: Up to 10 years and 11 months

Trial details

NCT IDNCT00980538

SponsorJanssen Sciences Ireland UC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-11-25

Results submitted2021-11-24

View on ClinicalTrials.gov More HIV Infections trials