DRUG
Enfuvirtide
90 mg/12h sc for 7 days
Metabolic Effects of Enfuvirtide in Healthy Volunteers
Status
Completed
Phase
Phase 4
Enrollment
15
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
0.9% saline solution/12h sc for 7 days
Timeline
From registration to results.
First posted
Apr 14, 2008
Study start
Sep 2005
Primary completion
Mar 2006
Study completion
Mar 2006
Results posted
Not reported
Registry updated
Apr 14, 2008
Outcomes
What the study measures.
Primary outcomes
Change in fasting plasma total cholesterol
Time frame · 6 weeks
Secondary outcomes
Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA
Time frame · 6 weeks
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- MALE
- 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
Study locations
1 registered sites.
Spain. Showing up to 24 locations stored in the fast local snapshot.
Hospital Clinic
Barcelona, Barcelona, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Enfuvirtide.
NCT IDStudyPhase / statusEnrollmentUpdated
Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)
French National Agency for Research on AIDS and Viral Hepatitis · HIV Infections · AIDS
Phase 3
Completed
195
2026-04
Efficacy and Tolerance of the Switch From Enfuvirtine to Raltegravir in Antiretroviral Therapy Regimen in HIV Patients With Undetectable Viral Load
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Phase 3
Completed
170
2026-04
Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients
ANRS, Emerging Infectious Diseases · HIV Infection · Liver Failure
Phase 1 / Phase 2
Completed
14
2026-04
Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)
French National Agency for Research on AIDS and Viral Hepatitis · Leukoencephalopathy, Progressive Multifocal · HIV Infections
Phase 2
Completed
30
2026-04
Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
University Hospital, Tours · HIV
Phase 3
Completed
224
2025-12
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
Gilead Sciences · HIV-1-infection
Phase 2 / Phase 3
Active, not recruiting
689
2025-10
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
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Early Phase 1
Completed
11
2021-11
Optimizing Treatment for Treatment-Experienced, HIV-Infected People
National Institute of Allergy and Infectious Diseases (NIAID) · HIV Infections
Phase 3
Completed
517
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.