Metabolic Effects of Enfuvirtide in Healthy Volunteers

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: Placebo; Drug: Enfuvirtide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00657761

ENF/01FD-05/UF1

EudraCT #: 2005-002018-39

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

15 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline solution 0.9% sc/12h for 7 days

Treatment:

Drug: Placebo

Enfuvirtide

Experimental group

Description:

Enfuvirtide 90 mg/12h sc for 7 days

Treatment:

Drug: Enfuvirtide