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Metabolic Effects of Enfuvirtide in Healthy Volunteers

This study has been completed.
Hoffmann-La Roche
Information provided by:
Hospital Clinic of Barcelona Identifier:
First received: April 8, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
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
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

Resource links provided by NLM:

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Change in fasting plasma total cholesterol [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA [ Time Frame: 6 weeks ]

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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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
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 identifier: NCT00657761

Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Hoffmann-La Roche
Principal Investigator: Neus Riba, MD Hospital Clinic of Barcelona
  More Information

Responsible Party: Jose M Gatell, Hospital Clinic, Barcelona 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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 21, 2017