A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Enfuvirtide 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Serious Adverse Events (SAEs) [Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)]
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.
- Number of Participants With Premature Withdrawal Due to Adverse Events [Up to 96 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Individuals at least 16 years of age infected with HIV-1
-
CD4 lymphocyte count less than equal to (<=) 100 cells per cubic millimeter (cells/mm^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (>=) 10,000 copies/mL while on highly active antiretroviral therapy (HAART)
-
Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens
Exclusion Criteria:
-
Evidence of ongoing alcohol and/or drug or substance abuse
-
Prior non-adherence to antiretroviral treatment regimens
-
Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bangkok | Thailand | 10110 | ||
| 2 | Bangkok | Thailand | 10330 | ||
| 3 | Bangkok | Thailand | 10700 | ||
| 4 | Chiang Mai | Thailand | 50200 | ||
| 5 | Nonthaburi | Thailand | 11000 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Chair: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML17819
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Enfuvirtide |
|---|---|
| Arm/Group Description | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
| Period Title: Overall Study | |
| STARTED | 23 |
| COMPLETED | 17 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | Enfuvirtide |
|---|---|
| Arm/Group Description | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
| Overall Participants | 23 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
42.17
(8.56)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
17.4%
|
| Male |
19
82.6%
|
Outcome Measures
| Title | Number of Participants With Serious Adverse Events (SAEs) |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
| Measure Participants | 23 |
| Number [participants] |
6
26.1%
|
| Title | Number of Participants With Premature Withdrawal Due to Adverse Events |
|---|---|
| Description | |
| Time Frame | Up to 96 weeks |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) |
| Measure Participants | 23 |
| Number [participants] |
1
4.3%
|
Adverse Events
| Time Frame | Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks) | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Enfuvirtide | |
| Arm/Group Description | Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) | |
All Cause Mortality |
||
| Enfuvirtide | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Enfuvirtide | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/23 (26.1%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/23 (4.3%) | |
| Gastrointestinal disorders | ||
| Pancreatitis acute | 1/23 (4.3%) | |
| Diarrhoea | 1/23 (4.3%) | |
| Abdominal pain | 1/23 (4.3%) | |
| Colitis | 1/23 (4.3%) | |
| Immune system disorders | ||
| Immune reconstitution inflammatory syndrome | 1/23 (4.3%) | |
| Infections and infestations | ||
| Cellulitis | 2/23 (8.7%) | |
| Nervous system disorders | ||
| Headache | 1/23 (4.3%) | |
| Brain stem stroke | 1/23 (4.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Bronchiectasis | 1/23 (4.3%) | |
Other (Not Including Serious) Adverse Events |
||
| Enfuvirtide | ||
| Affected / at Risk (%) | # Events | |
| Total | 23/23 (100%) | |
| Gastrointestinal disorders | ||
| Diarrhoea | 8/23 (34.8%) | |
| Nausea | 2/23 (8.7%) | |
| Vomiting | 2/23 (8.7%) | |
| General disorders | ||
| Injection site pain | 14/23 (60.9%) | |
| Injection site induration | 13/23 (56.5%) | |
| Injection site reaction | 5/23 (21.7%) | |
| Injection site haemorrhage | 6/23 (26.1%) | |
| Injection site rash | 5/23 (21.7%) | |
| Injection site oedema | 4/23 (17.4%) | |
| Injection site erythema | 3/23 (13%) | |
| Pyrexia | 2/23 (8.7%) | |
| Cold | 2/23 (8.7%) | |
| Infections and infestations | ||
| Cytomegalovirus infection | 3/23 (13%) | |
| Congenital herpes simplex infection | 2/23 (8.7%) | |
| Oral candidiasis | 2/23 (8.7%) | |
| Psychiatric disorders | ||
| Anorexia nervosa | 2/23 (8.7%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Upper respiratory tract infection | 6/23 (26.1%) | |
| Skin and subcutaneous tissue disorders | ||
| Ecchymosis | 2/23 (8.7%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
- ML17819