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NCT00232908 · ClinicalTrials.gov registry record · Phase 4
QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 361
- Enrollment target
NCT00232908: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00232908 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 361 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00232908, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 361 participants
- Enrollment target
Study Summary
This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled 8mm needle to administer Fuzeon. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG enfuvirtide [Fuzeon]
- DRUG ARV regimen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2004-06 |
| Est. Completion | 2005-10 |
| Phase | Phase 4 |
What the finished NCT00232908 record still lists
NCT00232908 is an interventional study that assigns participants to a tested intervention. The registered 361 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 (30% lower).
The record links to 0 conditions, and to 2 interventions - of which enfuvirtide [Fuzeon] is the first listed.
NCT00232908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00232908 about?
NCT00232908 is a clinical study titled "QUALITE Study - A Study of Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With Human Immunodeficiency Virus-1 (HIV-1) Infection". This study will evaluate patient quality of life and tolerability of a HAART (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of Fuzeon in clinically stable, treatment-experienced patients with HIV-1 infection. All patients will use a 31-gauge thin-walled...
What is the current status of trial NCT00232908?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 361 participants. The study started on 2004-06. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00232908?
The interventions under investigation include: enfuvirtide [Fuzeon] (DRUG), ARV regimen (DRUG).
Who is sponsoring clinical trial NCT00232908?
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 NCT00232908's enrollment target sits among peer trials
361 225th of 2000 higher than 1,776 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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