Metabolic Effects of Enfuvirtide in Healthy Volunteers
This study has been completed.
Sponsor:
Hospital Clinic of Barcelona
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
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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 (Adult) |
| 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
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
| 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:
|
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 |
ClinicalTrials.gov processed this record on September 29, 2016