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Completed Phase 4 Interventional Results available

BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.

ClinicalTrials.gov ID: NCT00326963

Public ClinicalTrials.gov record NCT00326963. 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 18, 2026, 2:38 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 Safety and Efficacy of a New Protease Inhibitor (Darunavir) With Fuzeon® (Enfuvirtide) Plus Background Antiretroviral Regimen in HIV-1 Infected, Triple-class Treatment-experienced Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.

Study identification

NCT ID
NCT00326963
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
142 participants

Conditions and interventions

Conditions

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
Mar 2006 (Type not available)
Primary completion
Apr 2007 (Actual)
Completion
May 2007 (Actual)
Last update posted
Aug 16, 2016

2006 – 2007

United States locations

U.S. sites
32
U.S. states
15
U.S. cities
28
Facility City State ZIP Site status
Not listed Phoenix Arizona 85006 —
Not listed Bakersfield California 93301 —
Not listed Beverly Hills California 90210 —
Not listed Los Angeles California 90027 —
Not listed Los Angeles California 90028 —
Not listed Los Angeles California 90036 —
Not listed San Francisco California 94114 —
Not listed Stanford California 94305 —
Not listed Tarzana California 91356 —
Not listed Norwalk Connecticut 06851 —
Not listed Washington D.C. District of Columbia 20009 —
Not listed Fort Lauderdale Florida 33334 —
Not listed Orlando Florida 32803 —
Not listed Port Saint Lucie Florida 34952 —
Not listed Decatur Georgia 30033 —
Not listed Macon Georgia 31201 —
Not listed Baltimore Maryland 21201 —
Not listed St Louis Missouri 63139 —
Not listed Newark New Jersey 07102 —
Not listed Somers Point New Jersey 08244 —
Not listed Albany New York 12208 —
Not listed New York New York 10003 —
Not listed New York New York 10032 —
Not listed Huntersville North Carolina 28078 —
Not listed Portland Oregon 97209-2534 —
Not listed Philadelphia Pennsylvania 19107 —
Not listed Dallas Texas 75246 —
Not listed Fort Worth Texas 76104 —
Not listed Houston Texas 77004 —
Not listed Houston Texas 77098 —
Not listed Annandale Virginia 22003 —
Not listed Hampton Virginia 23666 —

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 NCT00326963, 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 Aug 16, 2016 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00326963 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →