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

Completed · Phase 3

Conditions studied: HIV Infections, HIV-1

In brief

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.

Key facts

Study ID

NCT00980538

Run by

Janssen Sciences Ireland UC

People needed

180

Starts

2009-12-09

Expected to finish

2026-04-08

Last updated by the study team

2026-06-09

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Buenos Aires, Argentina
• Study site — Ciudad Autonoma de Buenos Aire, Argentina
• Study site — Belo Horizonte, Brazil
• Study site — Ribeirão Preto, Brazil
• Study site — Rio de Janeiro, Brazil
• Study site — Montreal, Quebec, Canada
• Study site — Lyon, France
• Study site — Paris, France
• Study site — Panama City, Panama
• Study site — Rio Piedras, Puerto Rico
• Study site — Bucharest, Romania
• Study site — Bloemfontein, South Africa
• Study site — Boksburg, South Africa
• Study site — Cape Town, South Africa
• Study site — Dundee, South Africa
• Study site — Durban, South Africa
• Study site — George, South Africa
• Study site — Johannesburg, South Africa
• Study site — Newtown, South Africa
• Study site — Pretoria, South Africa
• Study site — Esplugues de Llobregat, Spain

Full record on ClinicalTrials.gov

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