Metabolic Effects of Enfuvirtide in Healthy Volunteers

• Sponsor: Hospital Clinic of Barcelona (Other)
• Overall Status: Completed
• CT.gov ID: NCT00657761
• Collaborator: Hoffmann-La Roche (Industry)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Enfuvirtide; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Official Title: Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in fasting plasma total cholesterol [6 weeks]

Secondary Outcome Measures

1. Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinic	Barcelona		Spain	08036

Sponsors and Collaborators

• Hospital Clinic of Barcelona
• Hoffmann-La Roche

Investigators

• Principal Investigator: Neus Riba, MD, Hospital Clinic of Barcelona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00657761
• Other Study ID Numbers: ENF/01FD-05/UF1; EudraCT #: 2005-002018-39
• First Posted: Apr 14, 2008
• Last Update Posted: Apr 14, 2008
• Last Verified: Apr 1, 2008

• Additional relevant MeSH terms: HIV Infections; Enfuvirtide

Study Results

No Results Posted as of Apr 14, 2008