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NCT00089492 · ClinicalTrials.gov registry record · Phase 2
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients
A Phase 2 study of HIV Infections, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT00089492: Completed Phase 2 study of HIV Infections, sponsored by Hoffmann-La Roche.
NCT00089492 is a Phase 2 study of HIV Infections that has completed, run by Hoffmann-La Roche. The registered enrollment target is 64 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089492, a Phase 2 study of HIV Infections, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Conditions Studied
Interventions
- DRUG Optimized Background ARVs
- DRUG enfuvirtide [Fuzeon]
Study Locations (20)
Florida
- - Bradenton
- - Miami
- - North Miami Beach
- - Orlando
- - Sarasota
California
- - Fountain Valley
- - Los Angeles
- - Los Angeles
Pennsylvania
- - Allentown
- - Philadelphia
- - Philadelphia
Alabama
- - Hobson City
Colorado
- - Denver
Georgia
- - Atlanta
Louisiana
- - New Orleans
Massachusetts
- - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2004-07 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
What the finished NCT00089492 record still lists
NCT00089492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (86% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Optimized Background ARVs is the first listed.
NCT00089492 names 20 study sites across 12 states, led by Florida, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00089492 about?
NCT00089492 is a clinical study titled "A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients". This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by t...
What is the current status of trial NCT00089492?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2004-07. Estimated completion is 2006-06.
What conditions does trial NCT00089492 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00089492?
The interventions under investigation include: Optimized Background ARVs (DRUG), enfuvirtide [Fuzeon] (DRUG).
Who is sponsoring clinical trial NCT00089492?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00089492 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00089492's enrollment target sits among peer trials
64 321st of 542 higher than 222 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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