A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

ClinicalTrials.gov ID: NCT00488059

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.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 8:35 PM EDT

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
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 29 participants

Conditions and interventions

Conditions

HIV Infections

Interventions

Drug

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: May 31, 2007
Primary completion: Sep 30, 2008
Completion: Sep 30, 2008
Last update posted: Jul 21, 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 21, 2011 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00488059 live on ClinicalTrials.gov.

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