Trial Outcomes & Findings for A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection (NCT NCT02582983)

Last Updated: 2016-07-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)

Results posted on

2016-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Enfuvirtide Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Overall Study STARTED	23
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Enfuvirtide Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Overall Study Death	3
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enfuvirtide n=23 Participants Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Age, Continuous	42.17 years STANDARD_DEVIATION 8.56 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)

Population: The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Enfuvirtide n=23 Participants Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Number of Participants With Serious Adverse Events (SAEs)	6 participants

PRIMARY outcome

Timeframe: Up to 96 weeks

Population: The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Enfuvirtide n=23 Participants Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Number of Participants With Premature Withdrawal Due to Adverse Events	1 participants

Adverse Events

Enfuvirtide

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enfuvirtide n=23 participants at risk Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
Blood and lymphatic system disorders Anaemia	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Infections and infestations Cellulitis	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Gastrointestinal disorders Pancreatitis acute	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Gastrointestinal disorders Diarrhoea	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Gastrointestinal disorders Colitis	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Immune system disorders Immune reconstitution inflammatory syndrome	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Respiratory, thoracic and mediastinal disorders Bronchiectasis	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Nervous system disorders Headache	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Nervous system disorders Brain stem stroke	4.3% 1/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)

Other adverse events

Other adverse events
Measure	Enfuvirtide n=23 participants at risk Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
General disorders Injection site pain	60.9% 14/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Injection site induration	56.5% 13/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Injection site reaction	21.7% 5/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Injection site haemorrhage	26.1% 6/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Injection site rash	21.7% 5/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Injection site oedema	17.4% 4/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Injection site erythema	13.0% 3/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Skin and subcutaneous tissue disorders Ecchymosis	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Gastrointestinal disorders Diarrhoea	34.8% 8/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	26.1% 6/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Infections and infestations Cytomegalovirus infection	13.0% 3/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Psychiatric disorders Anorexia nervosa	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Pyrexia	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Infections and infestations Congenital herpes simplex infection	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Infections and infestations Oral candidiasis	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Gastrointestinal disorders Nausea	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Gastrointestinal disorders Vomiting	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
General disorders Cold	8.7% 2/23 • Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER