Metabolic Effects of Enfuvirtide in Healthy Volunteers

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

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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Placebo; Drug: Enfuvirtide

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Saline solution 0.9% sc/12h for 7 days	Drug: Placebo; 0.9% saline solution/12h sc for 7 days
Experimental: Enfuvirtide; Enfuvirtide 90 mg/12h sc for 7 days	Drug: Enfuvirtide; 90 mg/12h sc for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in fasting plasma total cholesterol	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA	6 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Hoffmann-La Roche
• Investigators: Principal Investigator: Neus Riba, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: April 8, 2008
• First Submitted That Met QC Criteria: April 8, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): April 14, 2008
• Last Update Submitted That Met QC Criteria: April 8, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Enfuvirtide
• Other Study ID Numbers: ENF/01FD-05/UF1; EudraCT #: 2005-002018-39