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NCT00980538 · ClinicalTrials.gov registry record · Phase 3
TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
A Phase 3 study of HIV Infections and HIV-1, sponsored by Janssen Sciences Ireland UC.
- Active
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT00980538: Active Phase 3 study of HIV Infections and HIV-1, sponsored by Janssen Sciences Ireland UC.
NCT00980538 is a Phase 3 study of HIV Infections and HIV-1 that is active but no longer recruiting, run by Janssen Sciences Ireland UC. The registered enrollment target is 180 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00980538, a Phase 3 study of HIV Infections and HIV-1, is active but no longer recruiting, sponsored by Janssen Sciences Ireland UC.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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 |
What the registry record for NCT00980538 still lists
NCT00980538 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (60% lower).
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.
NCT00980538 names 20 study sites across 6 states, led by Other, California, District of Columbia.
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.
What interventions are being tested in trial NCT00980538?
The interventions under investigation include: Etravirine (DRUG).
Who is sponsoring clinical trial NCT00980538?
This trial is sponsored by Janssen Sciences Ireland UC, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00980538's enrollment target sits among peer trials
180 189th of 542 higher than 350 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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