NCT00657761

Metabolic Effects of Enfuvirtide in Healthy Volunteers

Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Enfuvirtide	90 mg/12h sc for 7 days
DRUG	Placebo	0.9% saline solution/12h sc for 7 days

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2008-04-14
• Last updated: 2008-04-14

Locations

1 site across 1 country: Spain