A Phase 4 interventional study of Enfuvirtide in HIV Infections, sponsored by Hoffmann-La Roche. Completed at 5 sites in Thailand. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2016-07-06.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 23 is below the median of 120 across 4,201 interventional studies indexed under Infections.
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Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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Exclusion Criteria:
Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).
Drug: Enfuvirtide
All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.
Also known as: Fuzeon
Number of Participants With Serious Adverse Events (SAEs)
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)
Number of Participants With Premature Withdrawal Due to Adverse Events
Time frame: Up to 96 weeks
| Milestone | Enfuvirtide |
|---|---|
| Started | 23 |
| Completed | 17 |
| Not completed | 6 |
| Withdrew: Death | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Adverse event | 1 |
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.
| participants | Enfuvirtide |
|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | 6 |
| participants | Enfuvirtide |
|---|---|
| Number of Participants With Premature Withdrawal Due to Adverse Events | 1 |
Collected over Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enfuvirtide | — | 6/23 (26.1%) | 23/23 (100%) |
| Event | Enfuvirtide |
|---|---|
| CellulitisInfections and infestations | 2/23 |
| AnaemiaBlood and lymphatic system disorders | 1/23 |
| Pancreatitis acuteGastrointestinal disorders | 1/23 |
| DiarrhoeaGastrointestinal disorders | 1/23 |
| Abdominal painGastrointestinal disorders | 1/23 |
| ColitisGastrointestinal disorders | 1/23 |
| Immune reconstitution inflammatory syndromeImmune system disorders | 1/23 |
| BronchiectasisRespiratory, thoracic and mediastinal disorders | 1/23 |
| HeadacheNervous system disorders | 1/23 |
| Brain stem strokeNervous system disorders | 1/23 |
| Event | Enfuvirtide |
|---|---|
| Injection site painGeneral disorders | 14/23 |
| Injection site indurationGeneral disorders | 13/23 |
| DiarrhoeaGastrointestinal disorders | 8/23 |
| Injection site haemorrhageGeneral disorders | 6/23 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 6/23 |
| Injection site reactionGeneral disorders | 5/23 |
| Injection site rashGeneral disorders | 5/23 |
| Injection site oedemaGeneral disorders | 4/23 |
| Injection site erythemaGeneral disorders | 3/23 |
| Cytomegalovirus infectionInfections and infestations | 3/23 |
| Age, Continuous(years) | Enfuvirtide |
|---|---|
| Mean | 42.17 ± 8.56 |
| Sex: Female, Male(Participants) | Enfuvirtide |
|---|---|
| Female | 4 |
| Male | 19 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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