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:


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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
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 October 30, 2014