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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enfuvirtide | Experimental | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfuvirtide | Drug | All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks) |
| Number of Participants With Premature Withdrawal Due to Adverse Events | Up to 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | 10110 | Thailand | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Enfuvirtide | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enfuvirtide | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug. | Posted | Number | participants | Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks) |
|
Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enfuvirtide | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000077560 | Enfuvirtide |
| ID | Term |
|---|---|
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015700 | HIV Envelope Protein gp41 |
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| Bangkok |
| 10330 |
| Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Nonthaburi | 11000 | Thailand |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Premature Withdrawal Due to Adverse Events | The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug. | Posted | Number | participants | Up to 96 weeks |
|
|
|
| 6 |
| 23 |
| 23 |
| 23 |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Brain stem stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Anorexia nervosa | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Congenital herpes simplex infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cold | General disorders | MedDRA 18.1 | Systematic Assessment |
|
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.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014760 | Viral Fusion Proteins |
| D050576 | Membrane Fusion Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D015488 | HIV Antigens |
| D000956 | Antigens, Viral |
| D014764 | Viral Proteins |
| D054299 | env Gene Products, Human Immunodeficiency Virus |
| D015686 | Gene Products, env |
| D012191 | Retroviridae Proteins |
| D054298 | Human Immunodeficiency Virus Proteins |
| D014759 | Viral Envelope Proteins |
| D015678 | Viral Structural Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |