DRUG
enfuvirtide
Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
Status
Completed
Phase
Phase 4
Enrollment
6
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 6, 2015
Study start
Apr 2005
Primary completion
Oct 2007
Study completion
Oct 2007
Results posted
Not reported
Registry updated
Nov 2, 2016
Outcomes
What the study measures.
Primary outcomes
Percentage of participants who discontinue enfuvirtide due to adverse events\n
Time frame · Up to 102 weeks
Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
Time frame · Up to 102 weeks
Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
Time frame · Up to 102 weeks
Secondary outcomes
Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug
Time frame · Up to 28 days after discontinuation of enfuvirtide
Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR
Time frame · Up to 102 weeks
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Adult or adolescent patients greater than (\>)16 years of age * HIV-1 infection * CD4 count less than (\<)350/cubic millimeters (mm\^3) * HIV RNA viral load \>10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART) * Documented resistance, treatment-limiting toxicity, and/or \>=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs. Exclusion Criteria: * Women who are pregnant or breastfeeding; * Patients unable to self-inject; * Active, untreated opportunistic infection.
Study locations
1 registered sites.
Bulgaria. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Sofia, Bulgaria
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
French National Agency for Research on AIDS and Viral Hepatitis · HIV Infections
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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · HIV
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
2021-11
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.