Completed
Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
What is being tested
enfuvirtide
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 16 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: April 2005
Summary
Principal SponsorHoffmann-La Roche
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2005
Actual date on which the first participant was enrolled.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.
Official TitleOpen Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
Principal SponsorHoffmann-La Roche
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections
Criteria
5 inclusion criteria required to participate
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)
Show More Criteria
3 exclusion criteria prevent from participating
Women who are pregnant or breastfeeding;
Patients unable to self-inject;
Active, untreated opportunistic infection.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalParticipants will receive 180 milligrams (mg) of enfuvirtide adminstered twice daily as subcutaneous injections
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers