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
15 participants
INTERVENTIONAL
2005-09-30
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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Placebo
Saline solution 0.9% sc/12h for 7 days
Placebo
0.9% saline solution/12h sc for 7 days
Enfuvirtide
Enfuvirtide 90 mg/12h sc for 7 days
Enfuvirtide
90 mg/12h sc for 7 days
Interventions
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Enfuvirtide
90 mg/12h sc for 7 days
Placebo
0.9% saline solution/12h sc for 7 days
Eligibility Criteria
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Inclusion Criteria
* BMI between 19-24.9 kg/m2
* No active concomitant clinical conditions
* Negative HIV, HBV and HCV serologies
* Negative abuse drug urine test
Exclusion Criteria
* Prior dyslipemia
* Alcohol consumption \> 30g/day
* Caffeine consumption \> 5 units/day
* Current smoker
* Known drug allergies
* Participation in other drug trials in the previous 3 months
* No medications in the previous 30 days
18 Years
45 Years
MALE
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Hospital Clinic, Barcelona
Principal Investigators
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Neus Riba, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic
Barcelona, Barcelona, Spain
Countries
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Other Identifiers
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EudraCT #: 2005-002018-39
Identifier Type: -
Identifier Source: secondary_id
ENF/01FD-05/UF1
Identifier Type: -
Identifier Source: org_study_id