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
Public ClinicalTrials.gov record NCT00089492. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00089492
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2004
- Primary completion
- May 31, 2006
- Completion
- May 31, 2006
- Last update posted
- Nov 1, 2016
2004 – 2006
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Hobson City | Alabama | 36201 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Los Angeles | California | 90022 | — |
| Not listed | Los Angeles | California | 90048 | — |
| Not listed | Denver | Colorado | 80262 | — |
| Not listed | Bradenton | Florida | 34209 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | North Miami Beach | Florida | 33169 | — |
| Not listed | Orlando | Florida | 32803 | — |
| Not listed | Sarasota | Florida | 34239 | — |
| Not listed | Atlanta | Georgia | 30308 | — |
| Not listed | New Orleans | Louisiana | 70112 | — |
| Not listed | Boston | Massachusetts | 02118 | — |
| Not listed | Detroit | Michigan | 48202-2689 | — |
| Not listed | Union | New Jersey | 07083 | — |
| Not listed | Albany | New York | 12208 | — |
| Not listed | Allentown | Pennsylvania | 18102-7017 | — |
| Not listed | Philadelphia | Pennsylvania | 19102 | — |
| Not listed | Philadelphia | Pennsylvania | 19107 | — |
| Not listed | Austin | Texas | 78705 | — |
| Not listed | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00089492, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 1, 2016 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00089492 live on ClinicalTrials.gov.