Back to resultsA Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Bulgaria
Study Type
Interventional
Intervention
enfuvirtide
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Adult or adolescent patients greater than (>)16 years of age
- HIV-1 infection
- CD4 count less than (<)350/cubic millimeters (mm^3)
- HIV RNA viral load >10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
- Documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.
Exclusion Criteria:
- Women who are pregnant or breastfeeding;
- Patients unable to self-inject;
- Active, untreated opportunistic infection.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enfuvirtide
Arm Description
Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections
Outcomes
Primary Outcome Measures
Percentage of participants who discontinue enfuvirtide due to adverse events\n
Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
Secondary Outcome Measures
Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug
Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02569502
Brief Title
A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
Official Title
Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (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 will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 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
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enfuvirtide
Arm Type
Experimental
Arm Description
Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections
Intervention Type
Drug
Intervention Name(s)
enfuvirtide
Other Intervention Name(s)
Fuzeon
Intervention Description
Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
Primary Outcome Measure Information:
Title
Percentage of participants who discontinue enfuvirtide due to adverse events\n
Time Frame
Up to 102 weeks
Title
Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
Time Frame
Up to 102 weeks
Title
Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
Time Frame
Up to 102 weeks
Secondary Outcome Measure Information:
Title
Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug
Time Frame
Up to 28 days after discontinuation of enfuvirtide
Title
Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR
Time Frame
Up to 102 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult or adolescent patients greater than (>)16 years of age
HIV-1 infection
CD4 count less than (<)350/cubic millimeters (mm^3)
HIV RNA viral load >10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
Documented resistance, treatment-limiting toxicity, and/or >=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.
Exclusion Criteria:
Women who are pregnant or breastfeeding;
Patients unable to self-inject;
Active, untreated opportunistic infection.
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
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
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