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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00089492

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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:25 AM 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 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
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
64 participants

Conditions and interventions

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
Jul 2004 (Type not available)
Primary completion
Jun 2006 (Actual)
Completion
Jun 2006 (Actual)
Last update posted
Nov 2, 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 2, 2016 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00089492 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →