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NCT00657761 Clinical Trial

Metabolic Effects of Enfuvirtide in Healthy Volunteers

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00657761
Other study ID # ENF/01FD-05/UF1
Secondary ID EudraCT #: 2005-
Status Completed
Phase Phase 4
First received April 8, 2008
Last updated April 8, 2008
Start date September 2005
Est. completion date March 2006

Study information
Verified date April 2008
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• Enfuvirtide
90 mg/12h sc for 7 days
• Placebo
0.9% saline solution/12h sc for 7 days

Locations
Country Name City State
Spain Hospital Clinic Barcelona

Sponsors (2)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona Hoffmann-La Roche

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in fasting plasma total cholesterol 6 weeks Yes
Secondary Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA 6 weeks Yes
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