Metabolic Effects of Enfuvirtide in Healthy Volunteers

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Male

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 design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Collaborator: Hoffmann-La Roche
• Treatments: Enfuvirtide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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