BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00326963 |
Recruitment Status :
Completed
First Posted : May 17, 2006
Results First Posted : August 16, 2016
Last Update Posted : August 16, 2016
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Sponsor:
Hoffmann-La Roche
Collaborator:
Trimeris
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
HIV Infections |
Interventions |
Drug: Background ARVs Drug: PI Drug: enfuvirtide [Fuzeon] |
Enrollment | 142 |
Participant Flow
Recruitment Details | A total of 142 participants were enrolled in this study conducted from 6 March 2006 to 20 April 2007 at 33 centers to be investigated in the United States. |
Pre-assignment Details | A total of 142 participants were randomized, of which 140 received the study drug. A total of 2 randomized participants did not receive study drug. |
Arm/Group Title | Enfuvirtide+PI+ARV's |
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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). |
Period Title: Overall Study | |
Started | 140 |
Completed | 107 |
Not Completed | 33 |
Reason Not Completed | |
Adverse Event | 2 |
Injection site reaction | 1 |
Death | 1 |
Failure to return | 10 |
Withdrawal by Subject | 10 |
Refused treatment / did not cooperate | 5 |
Violation of selection criteria at entry | 2 |
Other protocol violation | 1 |
Administrative / other | 1 |
Baseline Characteristics
Arm/Group Title | Enfuvirtide+PI+ARV's | |
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Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½" needle/syringe, 31G 8 mm needle/syringe or B2000 NFID. | |
Overall Number of Baseline Participants | 142 | |
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Baseline analysis was performed on all randomized participants including two participants who does not received study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 142 participants | |
46.2 (7.68) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 142 participants | |
Female |
20 14.1%
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Male |
122 85.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Roche Trial Information Hotline |
Organization: | F. Hoffmann-La Roche AG |
Phone: | +41 616878333 |
EMail: | global.trial_information@roche.com |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00326963 |
Other Study ID Numbers: |
ML19712 |
First Submitted: | May 16, 2006 |
First Posted: | May 17, 2006 |
Results First Submitted: | March 23, 2016 |
Results First Posted: | August 16, 2016 |
Last Update Posted: | August 16, 2016 |