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

April 8, 2008
April 8, 2008
September 2005
March 2006   (final data collection date for primary outcome measure)
Change in fasting plasma total cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
HIV Infections
  • Drug: Enfuvirtide
    90 mg/12h sc for 7 days
  • Drug: Placebo
    0.9% saline solution/12h sc for 7 days
  • Placebo Comparator: Placebo
    Saline solution 0.9% sc/12h for 7 days
    Intervention: Drug: Placebo
  • Experimental: Enfuvirtide
    Enfuvirtide 90 mg/12h sc for 7 days
    Intervention: Drug: Enfuvirtide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2006
March 2006   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00657761
ENF/01FD-05/UF1, EudraCT #: 2005-002018-39
No
Jose M Gatell, Hospital Clinic, Barcelona
Hospital Clinic of Barcelona
Hoffmann-La Roche
Principal Investigator: Neus Riba, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP