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.
NCT ID: NCT00461266
Last Updated: 2016-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2007-04-30
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
enfuvirtide [Fuzeon]
90mg sc bid
Antiretroviral therapy
As prescribed
2
Antiretroviral therapy
As prescribed
Interventions
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enfuvirtide [Fuzeon]
90mg sc bid
Antiretroviral therapy
As prescribed
Eligibility Criteria
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Inclusion Criteria
* 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 non-adherence to antiretroviral treatment regimens;
* active opportunistic infection;
* currently taking, or anticipated to take during the study, any immunomodulator.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Carlton, , Australia
Darlinghurst, , Australia
Melbourne, , Australia
Miami, , Australia
Perth, , Australia
South Yarra, , Australia
Sydney, , Australia
Countries
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Other Identifiers
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ML19355
Identifier Type: -
Identifier Source: org_study_id
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