Metabolic Effects of Enfuvirtide in Healthy Volunteers

Hospital Clinic of Barcelona15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

HIV Infections

Interventions

EnfuvirtideDRUG

90 mg/12h sc for 7 days

PlaceboDRUG

0.9% saline solution/12h sc for 7 days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinic

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Change in fasting plasma total cholesterol

Time frame: 6 weeks

Secondary Outcomes

Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA

Time frame: 6 weeks

Data from ClinicalTrials.gov

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