NCT00980538CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (actual)
- First submitted
- 18 Sept 2009
- Start date
- 9 Dec 2009
- Primary completion date
- 25 Nov 2020
- Lead sponsor
- Janssen Sciences Ireland UC
- Diseases
- HIV
- NCT number
- NCT00980538
- EudraCT number
- 2009-013126-16
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 180
- From 9 Dec 2009 to the primary completion date, 25 Nov 2020
- 29 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR
- 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)
Lab values
- 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
Other
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.