Status:
COMPLETED
Metabolic Effects of Enfuvirtide in Healthy Volunteers
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
HIV Infections
Eligibility:
MALE
18-45 years
Phase:
PHASE4
Brief Summary
The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents. A short-term study in healthy volunteers, with a double-blind crossover ...
Eligibility Criteria
Inclusion
- Healthy adult males
- BMI between 19-24.9 kg/m2
- No active concomitant clinical conditions
- Negative HIV, HBV and HCV serologies
- Negative abuse drug urine test
Exclusion
- Prior psychiatric illness
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00657761
Start Date
September 1 2005
End Date
March 1 2006
Last Update
April 14 2008
Active Locations (1)
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1
Hospital Clinic
Barcelona, Barcelona, Spain, 08036