A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
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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: NCT02582983 |
Recruitment Status :
Completed
First Posted : October 21, 2015
Results First Posted : July 6, 2016
Last Update Posted : July 6, 2016
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Sponsor:
Hoffmann-La Roche
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 |
Intervention |
Drug: Enfuvirtide |
Enrollment | 23 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Enfuvirtide |
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Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
Period Title: Overall Study | |
Started | 23 |
Completed | 17 |
Not Completed | 6 |
Reason Not Completed | |
Death | 3 |
Withdrawal by Subject | 2 |
Adverse Event | 1 |
Baseline Characteristics
Arm/Group Title | Enfuvirtide | |
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Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) | |
Overall Number of Baseline Participants | 23 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 23 participants | |
42.17 (8.56) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 23 participants | |
Female |
4 17.4%
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Male |
19 82.6%
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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: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800-821-8590 |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02582983 |
Other Study ID Numbers: |
ML17819 |
First Submitted: | October 8, 2015 |
First Posted: | October 21, 2015 |
Results First Submitted: | May 25, 2016 |
Results First Posted: | July 6, 2016 |
Last Update Posted: | July 6, 2016 |