DRUG
enfuvirtide [Fuzeon]
90mg sc bid
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.
Status
Withdrawn
Phase
Phase 4
Enrollment
0
Locations
7
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Antiretroviral therapy
As prescribed
Timeline
From registration to results.
First posted
Apr 17, 2007
Study start
Apr 2007
Primary completion
Jan 2008
Study completion
Jan 2008
Results posted
Not reported
Registry updated
Aug 24, 2016
Outcomes
What the study measures.
Primary outcomes
Mean change in CD4 cell count from baseline
Time frame · Week 24
Secondary outcomes
Change in HIV RNA from baseline
Time frame · Week 24
Change in HIV RNA and CD4 cell count
Time frame · Weeks 24-48
Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.
Time frame · Throughout study
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
7 registered sites.
Australia. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Carlton, Australia
Facility not named
Darlinghurst, Australia
Facility not named
Melbourne, Australia
Facility not named
Miami, Australia
Facility not named
Perth, Australia
Facility not named
South Yarra, Australia
Facility not named
Sydney, Australia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Enfuvirtide.
NCT IDStudyPhase / statusEnrollmentUpdated
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Put the record in context.
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