NEWS HIGHLIGHTSMedia Articles Related to Fuzeon (Enfuvirtide)
Synthetic Agents Related To Active Ingredient In Marijuana Weaken HIV Infection
Source: HIV / AIDS News From Medical News Today [2013.05.04]
HIV, the virus that causes AIDS, is notorious for hiding within certain types of cells, where it reproduces at a slowed rate and eventually gives rise to chronic inflammation, despite drug therapy...
Baby "Cured" of HIV Infection
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2013.04.03]
Title: Baby "Cured" of HIV Infection
Category: Doctor's & Expert's views on Symptoms
Created: 4/3/2013 6:12:00 PM
Last Editorial Review: 4/3/2013 6:12:53 PM
Everyone Aged 15 To 65 Should Receive HIV Testing, New Guidelines Say
Source: HIV / AIDS News From Medical News Today [2013.04.30]
Clinicians are now recommended to screen all patients aged 15 to 65, and other teens or older adults who are at an elevated risk for HIV infection, according to new guidelines released today. The guidelines were part of the final recommendation statement on screening for HIV by the U.S...
Latest HIV Vaccine Fails In The US, Government Stops Study
Source: HIV / AIDS News From Medical News Today [2013.04.26]
A study testing the latest experimental HIV vaccine has been stopped after an independent review board found that it did not prevent HIV infection and did not decrease the amount of HIV in the blood. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will stop giving doses of this experimental vaccine...
Published Studies Related to Fuzeon (Enfuvirtide)
Efficacy and safety of raltegravir in treatment-experienced HIV-1-infected patients switching from enfuvirtide-based regimens: 48 week results of the randomized EASIER ANRS 138 trial. [2011.09]
OBJECTIVES: To assess the sustainable efficacy and safety of a switch from enfuvirtide to raltegravir in patients with multidrug-resistant HIV infection... CONCLUSIONS: In well-suppressed patients with multidrug-resistant HIV infection, a switch from enfuvirtide to raltegravir is generally well tolerated and has sustained antiviral efficacy when combined with a potent background regimen.
The effects of enfuvirtide therapy on body composition and metabolic parameters over 48 weeks in the TORO body imaging substudy. [2011.01]
OBJECTIVE: The aim of the study was to compare the metabolic and morphological effects of enfuvirtide plus an optimized background (OB) regimen vs. OB alone (control group) in treatment-experienced patients in the T-20 vs. Optimized Regimen Only (TORO) studies... CONCLUSION: The addition of enfuvirtide to an OB regimen does not appear to have unfavourable effects on fat distribution or metabolic parameters. (c) 2010 British HIV Association.
Impact on health-related quality of life of a switch from enfuvirtide to raltegravir among multidrug-resistant HIV-1-infected patients: a randomized open-label trial (EASIER-ANRS 138). [2010.09]
BACKGROUND: among multidrug-resistant HIV-1-infected patients, enfuvirtide has demonstrated sustained efficacy, but long-term use is inconvenient due to twice-daily subcutaneous injections which often induce injection-site reactions. We investigated whether a switch from enfuvirtide to raltegravir, an orally available HIV-integrase inhibitor, may improve health-related quality of life (HRQoL)... CONCLUSION: among multidrug-resistant HIV-1-infected patients, a switch from enfuvirtide to raltegravir resulted in statistically significant improvements in multiple HRQoL dimensions over 24 weeks in comparison to the maintenance under 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.
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.
Reports of Suspected Fuzeon (Enfuvirtide) Side Effects
Premature Rupture of Membranes (5),
Neutropenia (5),
Pancytopenia (4),
Leukopenia (4),
Plagiocephaly (3),
Premature Baby (3),
Expired Drug Administered (2),
Disorientation (2),
Maternal Exposure During Pregnancy (2),
Skin Disorder (2), more >>
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