Back to resultsESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
Primary Purpose
HIV Infections
Status
Withdrawn
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
enfuvirtide [Fuzeon]
Antiretroviral therapy
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- documented chronic HIV infection;
- currently receiving a stable antiretroviral regimen;
- CD4 cell count <250 cells/mm3;
- HIV RNA viral load <400 copies/mL for >12 months.
Exclusion Criteria:
- prior exposure to Fuzeon;
- prior non-adherence to antiretroviral treatment regimens;
- active opportunistic infection;
- currently taking, or anticipated to take during the study, any immunomodulator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Mean change in CD4 cell count from baseline
Secondary Outcome Measures
Change in HIV RNA from baseline
Change in HIV RNA and CD4 cell count
Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00461266
Brief Title
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
Official Title
A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-infected Fuzeon-naïve Patients With Sustained HIV Viral Suppression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Slow recruitment
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (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 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
enfuvirtide [Fuzeon]
Intervention Description
90mg sc bid
Intervention Type
Drug
Intervention Name(s)
Antiretroviral therapy
Intervention Description
As prescribed
Primary Outcome Measure Information:
Title
Mean change in CD4 cell count from baseline
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change in HIV RNA from baseline
Time Frame
Week 24
Title
Change in HIV RNA and CD4 cell count
Time Frame
Weeks 24-48
Title
Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
documented chronic HIV infection;
currently receiving a stable antiretroviral regimen;
CD4 cell count <250 cells/mm3;
HIV RNA viral load <400 copies/mL for >12 months.
Exclusion Criteria:
prior exposure to Fuzeon;
prior non-adherence to antiretroviral treatment regimens;
active opportunistic infection;
currently taking, or anticipated to take during the study, any immunomodulator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Carlton
Country
Australia
City
Darlinghurst
Country
Australia
City
Melbourne
Country
Australia
City
Miami
Country
Australia
City
Perth
Country
Australia
City
South Yarra
Country
Australia
City
Sydney
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
We'll reach out to this number within 24 hrs