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A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection

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ClinicalTrials.gov Identifier: NCT02582983
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Enfuvirtide
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enfuvirtide
Hide Arm/Group Description 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
Arm/Group Title Enfuvirtide
Hide Arm/Group Description Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants
42.17  (8.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
4
  17.4%
Male
19
  82.6%
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe.
Time Frame Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.
Arm/Group Title Enfuvirtide
Hide Arm/Group Description:
Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
6
2.Primary Outcome
Title Number of Participants With Premature Withdrawal Due to Adverse Events
Hide Description [Not Specified]
Time Frame Up to 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.
Arm/Group Title Enfuvirtide
Hide Arm/Group Description:
Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
1
Time Frame Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enfuvirtide
Hide Arm/Group Description Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
All-Cause Mortality
Enfuvirtide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enfuvirtide
Affected / at Risk (%)
Total   6/23 (26.09%) 
Blood and lymphatic system disorders   
Anaemia † 1  1/23 (4.35%) 
Gastrointestinal disorders   
Pancreatitis acute † 1  1/23 (4.35%) 
Diarrhoea † 1  1/23 (4.35%) 
Abdominal pain † 1  1/23 (4.35%) 
Colitis † 1  1/23 (4.35%) 
Immune system disorders   
Immune reconstitution inflammatory syndrome † 1  1/23 (4.35%) 
Infections and infestations   
Cellulitis † 1  2/23 (8.70%) 
Nervous system disorders   
Headache † 1  1/23 (4.35%) 
Brain stem stroke † 1  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders   
Bronchiectasis † 1  1/23 (4.35%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enfuvirtide
Affected / at Risk (%)
Total   23/23 (100.00%) 
Gastrointestinal disorders   
Diarrhoea † 1  8/23 (34.78%) 
Nausea † 1  2/23 (8.70%) 
Vomiting † 1  2/23 (8.70%) 
General disorders   
Injection site pain † 1  14/23 (60.87%) 
Injection site induration † 1  13/23 (56.52%) 
Injection site reaction † 1  5/23 (21.74%) 
Injection site haemorrhage † 1  6/23 (26.09%) 
Injection site rash † 1  5/23 (21.74%) 
Injection site oedema † 1  4/23 (17.39%) 
Injection site erythema † 1  3/23 (13.04%) 
Pyrexia † 1  2/23 (8.70%) 
Cold † 1  2/23 (8.70%) 
Infections and infestations   
Cytomegalovirus infection † 1  3/23 (13.04%) 
Congenital herpes simplex infection † 1  2/23 (8.70%) 
Oral candidiasis † 1  2/23 (8.70%) 
Psychiatric disorders   
Anorexia nervosa † 1  2/23 (8.70%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract infection † 1  6/23 (26.09%) 
Skin and subcutaneous tissue disorders   
Ecchymosis † 1  2/23 (8.70%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
[Not Specified]
Certain Agreements
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     History of Changes
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