BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
NCT ID: NCT00326963
Last Updated: 2016-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
142 participants
INTERVENTIONAL
2006-03-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enfuvirtide+PI+ARV's
Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½" needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
Background ARVs
As prescribed
PI
As prescribed
enfuvirtide [Fuzeon]
90mg sc bid
Interventions
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Background ARVs
As prescribed
PI
As prescribed
enfuvirtide [Fuzeon]
90mg sc bid
Eligibility Criteria
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Inclusion Criteria
* seropositive for HIV-1;
* enrolled in an early access program for a new investigational PI;
* naive to Fuzeon, and the investigational PI;
* treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Exclusion Criteria
* evidence of active, untreated opportunistic infection;
* malignancy requiring chemotherapy or radiotherapy.
18 Years
ALL
No
Sponsors
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Trimeris
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Phoenix, Arizona, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Stanford, California, United States
Tarzana, California, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Orlando, Florida, United States
Port Saint Lucie, Florida, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Somers Point, New Jersey, United States
Albany, New York, United States
New York, New York, United States
New York, New York, United States
Huntersville, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Annandale, Virginia, United States
Hampton, Virginia, United States
Brisbane, , Australia
Carlton, , Australia
Liverpool, , Australia
Melbourne, , Australia
South Yarra, , Australia
Sydney, , Australia
Countries
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Other Identifiers
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ML19712
Identifier Type: -
Identifier Source: org_study_id
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