HIV Infections
Conditions
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.
Interventions
DRUGEnfuvirtide
90 mg/12h sc for 7 days
DRUGPlacebo
0.9% saline solution/12h sc for 7 days
Sponsors
Hoffmann-La Roche
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting plasma total cholesterol | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA | 6 weeks |
Countries
Spain
Outcome results
None listed