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TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
NCT00980538 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Etravirine
Study Locations (20)
Other
- — Buenos Aires
- — Ciudad Autonoma de Buenos Aire
- — Belo Horizonte
- — Ribeirão Preto
- — Rio de Janeiro
- — Lyon
- — Paris
- — Panama City
- — Rio Piedras
- — Bucharest
- — Bloemfontein
- — Boksburg
- — Cape Town
- — Dundee
- — Durban
California
- — Los Angeles
District of Columbia
- — Washington D.C.
New York
- — New York
Pennsylvania
- — Philadelphia
Quebec
- — Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2009-12-09 |
| Est. Completion | 2026-04-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00980538
The ClinicalTrials.gov registry entry for NCT00980538 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Sciences Ireland UC, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention — of which Etravirine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00980538 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00980538 about?
NCT00980538 is a clinical study titled "TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants". 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 \[example, access program or government program\]), o...
What is the current status of trial NCT00980538?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2009-12-09. Estimated completion is 2026-04-16.
What conditions does trial NCT00980538 study?
This clinical trial studies the following conditions: HIV Infections, HIV-1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00980538?
The interventions under investigation include: Etravirine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00980538?
This trial is sponsored by Janssen Sciences Ireland UC, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00980538 being conducted?
This trial has 20 study locations across California, District of Columbia, New York, Pennsylvania, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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