A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
Public ClinicalTrials.gov record NCT00488059. 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 Multicenter, Open-label Study Evaluating the Antiviral Activity and Safety of Enfuvirtide (ENF) Once Daily (QD) or Twice Daily (BID) in Triple-class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care (SOC) Regimen That Includes Initiating Raltegravir Plus an Optimized Background (OB) Antiviral Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.
Study identification
- NCT ID
- NCT00488059
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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 2007 (Type not available)
- Primary completion
- Oct 2008 (Actual)
- Completion
- Oct 2008 (Actual)
- Last update posted
- Jul 22, 2011
2007 – 2008
United States locations
- U.S. sites
- 41
- U.S. states
- 15
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Hobson City | Alabama | 36201 | — |
| Not listed | Phoenix | Arizona | 85006 | — |
| Not listed | Los Angeles | California | 90027 | — |
| Not listed | Los Angeles | California | 90028 | — |
| Not listed | Los Angeles | California | 90036 | — |
| Not listed | Los Angeles | California | 90069 | — |
| Not listed | Modesto | California | 95350 | — |
| Not listed | Stanford | California | 94305 | — |
| Not listed | Washington D.C. | District of Columbia | 20009 | — |
| Not listed | Fort Lauderdale | Florida | 33307 | — |
| Not listed | Fort Lauderdale | Florida | 33334 | — |
| Not listed | Fort Myers | Florida | 39912 | — |
| Not listed | Miami | Florida | 33133 | — |
| Not listed | Miami Beach | Florida | 33139 | — |
| Not listed | North Palm Beach | Florida | 33408 | — |
| Not listed | Orlando | Florida | 32803 | — |
| Not listed | Plantation | Florida | 33317 | — |
| Not listed | Port Saint Lucie | Florida | 34952 | — |
| Not listed | Safety Harbor | Florida | 36495 | — |
| Not listed | South Miami | Florida | 33143 | — |
| Not listed | Tampa | Florida | 33614 | — |
| Not listed | Atlanta | Georgia | 30309 | — |
| Not listed | Atlanta | Georgia | 30318 | — |
| Not listed | Macon | Georgia | 31201 | — |
| Not listed | Chicago | Illinois | 60657 | — |
| Not listed | Silver Spring | Maryland | 20910 | — |
| Not listed | Boston | Massachusetts | 02215-3318 | — |
| Not listed | Kansas City | Missouri | 64111 | — |
| Not listed | St Louis | Missouri | 63139 | — |
| Not listed | Newark | New Jersey | 07102 | — |
| Not listed | Briarcliff Manor | New York | 10510 | — |
| Not listed | New York | New York | 10003 | — |
| Not listed | Rochester | New York | 14604 | — |
| Not listed | The Bronx | New York | 10467-2490 | — |
| Not listed | Allentown | Pennsylvania | 18102-7017 | — |
| Not listed | Philadelphia | Pennsylvania | 19107 | — |
| Not listed | Reading | Pennsylvania | 19601 | — |
| Not listed | Dallas | Texas | 75246 | — |
| Not listed | Fort Worth | Texas | 76104 | — |
| Not listed | Houston | Texas | 77098 | — |
| Not listed | Annandale | Virginia | 22003 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00488059, 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 Jul 22, 2011 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00488059 live on ClinicalTrials.gov.