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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 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 361 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00232908
The ClinicalTrials.gov registry entry for NCT00232908 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 361 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 2 interventions - of which enfuvirtide [Fuzeon] is the first listed.
NCT00232908 reports 0 study locations.
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.
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