A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
NCT ID: NCT02569502
Last Updated: 2016-11-02
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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COMPLETED
PHASE4
6 participants
INTERVENTIONAL
2005-04-30
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enfuvirtide
Participants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections
enfuvirtide
Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
Interventions
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enfuvirtide
Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients unable to self-inject;
* Active, untreated opportunistic infection.
16 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_CHAIR
Hoffmann-La Roche
Locations
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Sofia, , Bulgaria
Countries
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Other Identifiers
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ML18634
Identifier Type: -
Identifier Source: org_study_id