Metabolic Effects of Enfuvirtide in Healthy Volunteers
- Registration Number
- NCT00657761
- Lead Sponsor
- Hospital Clinic of Barcelona
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Saline solution 0.9% sc/12h for 7 days Enfuvirtide Enfuvirtide Enfuvirtide 90 mg/12h sc for 7 days
- Primary Outcome Measures
Name Time Method Change in fasting plasma total cholesterol 6 weeks
- Secondary Outcome Measures
Name Time Method Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA 6 weeks
Trial Locations
- Locations (1)
Hospital Clinic
🇪🇸Barcelona, Spain