NEWS HIGHLIGHTS
Published Studies Related to Fuzeon (Enfuvirtide)
Immunological success is predicted by enfuvirtide but not interleukin-2 therapy in immunodepressed patients. [2009.07.17]
OBJECTIVES: To evaluate the efficacy of adding interleukin-2 (IL-2) to an optimized background treatment in HIV-1 patients with advanced failure. DESIGN: Randomized, open-label, multicentre controlled trial... CONCLUSION: IL-2 failed to increase CD4 cell count in immunocompromised patients with multiple therapeutic failures. Enfuvirtide use was highly associated with success.
A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study. [2008.12]
OBJECTIVES: The aim of the study was to compare the efficacy and safety of induction with the addition of enfuvirtide to a newly designed oral, highly active antiretroviral therapy (HAART) regimen versus HAART alone followed by a maintenance phase wherein participants were randomized to either continue/discontinue enfuvirtide while maintaining HAART or continue HAART alone (NCT00487188)... CONCLUSIONS: Although limited by small participant numbers, these results suggest that treatment with enfuvirtide added to HAART may be an option for many patients.
Adherence to enfuvirtide and its impact on treatment efficacy. [2008.02]
High adherence rates to antiretroviral (ARV) therapy are associated with increased durability of viral suppression and decreased rates of drug resistance. The requirement of twice-daily subcutaneous self-administration of enfuvirtide (ENF) has raised concerns about adherence.In addition, the inclusion of ENF did not negatively impact adherence to the ARV regimen as a whole.
A randomized study to evaluate injection site reactions using three different enfuvirtide delivery mechanisms (the OPTIONS study). [2008]
BACKGROUND: The antiretroviral enfuvirtide (ENF) is injected subcutaneously using a 27-gauge needle. Injection site reactions (ISRs) can affect long-term ENF tolerability. Alternative ENF delivery methods may ameliorate ISRs... CONCLUSION: Needle-free ENF injection offers a reasonable, reliable alternative to needle-based injecting in this population, at least in the short term.
Short communication safety, tolerability and pharmacokinetics of enfuvirtide administered by a needle-free injection system compared with subcutaneous injection. [2008]
BACKGROUND: Injection site reactions (ISRs) can present a challenge to patients when using enfuvirtide (ENF). This study compared ISRs associated with use of a needle-free injection device (NFID) with those associated with a standard 27-gauge half-inch needle/syringe (NS)... CONCLUSIONS: Compared with a standard NS, use of an NFID to administer ENF was associated with a substantially lower incidence of painful ISRs, was generally safe and well-tolerated, and was preferred by most participants in the study.
Clinical Trials Related to Fuzeon (Enfuvirtide)
Cohort Study for Patients Using Fuzeon (Enfuvirtide) [Active, not recruiting]
The Radata-Fuzeon cohort is an observational cohort study to gain a better understanding of
Fuzeon (Enfuvirtide) in daily clinical practice. Patients planned to take this drug in a new
antiretroviral combination therapy (ART) are eligible to participate in this observation.
Physicians may register patients online via the internet. They are offered to get an expert
advice suggesting therapeutics for a new ART.
Observation interval is every three month. However physicians are allowed to initiate new
diagnostics, expert advice and therapeutic changes independently from these intervals if
necessary.
Total observation time for each patients is planned for two years.
WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV. [Completed]
The purpose of this study is to evaluate the tolerability of a subcutaneous needle-free
injection device used to administer Fuzeon, compared with the standard needle/syringe
supplied with commercial Fuzeon. The anticipated time on study treatment is <3 months, and
the target sample size is <100 individuals.
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression. [Terminated]
This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral
regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an
HIV RNA viral load <400 copies/mL. Eligible patients will be randomized to receive Fuzeon
90mg bid sc in addition to their current antiretroviral therapy, or to continue their current
antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the
target sample size is <100 individuals.
AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients. [Active, not recruiting]
This 2 arm study will evaluate the efficacy and safety of Fuzeon with an integrase inhibitor
in an expanded access program plus optimized background in HIV-1 infected patients naive to
Fuzeon and an integrase inhibitor. In the first cohort phase of the study, eligible patients
will receive Fuzeon 90mg sc b. i.d. until confirmation of response (min/max = 8/16 weeks). In
the second, randomised comparator phase of the study, responders will be randomized to
receive Fuzeon either 90mg sc b. i.d. or 180mg qd for a further 24 weeks. Non-responders and
virological failures will be terminated from the study. The anticipated time on study
treatment is 3-12 months, and the target sample size is 100-500 individuals.
Pilot Study Evaluating Interruption of Enfuvirtide (Fuzeon, T20) in Patients With Enfuvirtide Resistance [Active, not recruiting]
The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV
activity in patients experiencing an incomplete virologic response to an enfuvirtide-based
regimen.
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