Back to resultsA Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Enfuvirtide
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enfuvirtide
Arm Description
Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).
Outcomes
Primary Outcome Measures
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.
Number of Participants With Premature Withdrawal Due to Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02582983
Brief Title
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Official Title
An Open-Label Safety Trial of Enfuvirtide (T-20/RO 29-9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiviral Regimen in Thai Patients With Advanced HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enfuvirtide
Arm Type
Experimental
Arm Description
Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).
Intervention Type
Drug
Intervention Name(s)
Enfuvirtide
Other Intervention Name(s)
Fuzeon
Intervention Description
All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.
Primary Outcome Measure Information:
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)
Title
Number of Participants With Premature Withdrawal Due to Adverse Events
Time Frame
Up to 96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Bangkok
ZIP/Postal Code
10110
Country
Thailand
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
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