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Metabolic Effects of Enfuvirtide in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00657761
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : April 14, 2008
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hospital Clinic of Barcelona

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide
U.S. FDA Resources

Arms and Interventions
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: April 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
 Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents