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NCT00326963 · ClinicalTrials.gov registry record · Phase 4
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 142
- Enrollment target
NCT00326963 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 142 participants.
The verdict
NCT00326963, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 142 participants
- Enrollment target
Study Summary
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.
Interventions
- DRUG PI
- DRUG enfuvirtide [Fuzeon]
- DRUG Background ARVs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2006-03 |
| Est. Completion | 2007-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00326963
The ClinicalTrials.gov registry entry for NCT00326963 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 142 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 3 interventions - of which PI is the first listed.
NCT00326963 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00326963 about?
NCT00326963 is a clinical study titled "BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.". This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administ...
What is the current status of trial NCT00326963?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 142 participants. The study started on 2006-03. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00326963?
The interventions under investigation include: PI (DRUG), enfuvirtide [Fuzeon] (DRUG), Background ARVs (DRUG).
Who is sponsoring clinical trial NCT00326963?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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