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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Enfuvirtide Drug: Placebo | Phase 4 |
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 |

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
|
- Change in fasting plasma total cholesterol [ Time Frame: 6 weeks ]
- Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA [ Time Frame: 6 weeks ]

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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

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
Spain | |
Hospital Clinic | |
Barcelona, Spain, 08036 |
Principal Investigator: | Neus Riba, MD | Hospital Clinic of Barcelona |
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 |