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NCT00337701 · ClinicalTrials.gov registry record · Phase 4
BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 326
- Enrollment target
NCT00337701: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00337701 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 326 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00337701, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 326 participants
- Enrollment target
Study Summary
This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of Fuzeon with the standard needle and syringe. Patients will be randomized to the B2000 device or the standard needle and syringe for 4 weeks; all patients will use the B2000 device for the next 4 weeks. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG enfuvirtide [Fuzeon]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2006-06 |
| Est. Completion | 2007-01 |
| Phase | Phase 4 |
What the finished NCT00337701 record still lists
NCT00337701 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which enfuvirtide [Fuzeon] is the first listed.
NCT00337701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00337701 about?
NCT00337701 is a clinical study titled "BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection". This study will evaluate the signs and symptoms associated with Fuzeon injection (90mg sc) using the B2000 needle-free injection device, in HIV-1 positive patients experienced to Fuzeon treatment, but having difficulty tolerating long-term (\>4 weeks) administration of Fuzeon with the standard needl...
What is the current status of trial NCT00337701?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 326 participants. The study started on 2006-06. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00337701?
The interventions under investigation include: enfuvirtide [Fuzeon] (DRUG).
Who is sponsoring clinical trial NCT00337701?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00337701's enrollment target sits among peer trials
326 253rd of 2000 higher than 1,747 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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