Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT00326963 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 142 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples for HIV-1 RNA viral load measurement were collected at the Week 24 clinic visit. The number of participants with HIV-1 RNA viral load results \<50 copies/mL is reported.
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 |
What the finished NCT00326963 record still lists
NCT00326963 is an interventional study that assigns participants to a tested intervention. The registered 142 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 (73% lower).
The record links to 0 conditions, and to 3 interventions - of which PI is the first listed.
NCT00326963 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00326963's enrollment target sits among peer trials
142 580th of 2000 higher than 1,421 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03933631 · 142 participants · Phase 3
Pilocarpine Use After Kahook Goniotomy
- NCT04938349 · 142 participants · NA
Dual Task Perturbation Training for OAwMCI
- NCT06117254 · 142 participants · NA
Hearing Aids for Veterans With Functional Hearing Difficulties
- NCT06463665 · 142 participants · Phase 2
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia