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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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 326 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00337701
The ClinicalTrials.gov registry entry for NCT00337701 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which enfuvirtide [Fuzeon] is the first listed.
NCT00337701 reports 0 study locations.
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.
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