Metabolic Effects of Enfuvirtide in Healthy Volunteers

This study has been completed.

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by:

Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT00657761

First received: April 8, 2008

Last updated: NA

Last verified: April 2008

History: No changes posted

Purpose

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	Intervention	Phase
HIV Infections	Drug: Enfuvirtide Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title:	Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Enfuvirtide

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Change in fasting plasma total cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	15
Study Start Date:	September 2005
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657761

Locations


Spain
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

More Information

No publications provided


Responsible Party:	Jose M Gatell, Hospital Clinic, Barcelona
ClinicalTrials.gov Identifier:	NCT00657761 History of Changes
Other Study ID Numbers:	ENF/01FD-05/UF1, EudraCT #: 2005-002018-39
Study First Received:	April 8, 2008
Last Updated:	April 8, 2008
Health Authority:	Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:


Enfuvirtide Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents	HIV Fusion Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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