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.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: enfuvirtide [Fuzeon] (Drug); Antiretroviral therapy (Drug)
Phase: Phase 4
Sponsored by: Hoffmann-La Roche
Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
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.
Official title: A Randomized, Open Label Study to Determine the Immunological Benefits of Adding Fuzeon to an Antiretroviral Regimen in HIV-Infected Fuzeon-na´ve Patients With Sustained HIV Viral Suppression
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Mean change in CD4 cell count from baseline
Change in HIV RNA from baseline
Change in HIV RNA and CD4 cell count
Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.
Minimum age: 18 Years.
Maximum age: N/A.
- adult patients, >=18 years of age;
- documented chronic HIV infection;
- currently receiving a stable antiretroviral regimen;
- CD4 cell count <250 cells/mm3;
- HIV RNA viral load <400 copies/mL for >12 months.
- prior exposure to Fuzeon;
- prior non-adherence to antiretroviral treatment regimens;
- active opportunistic infection;
- currently taking, or anticipated to take during the study, any immunomodulator.
Locations and Contacts
South Yarra, Australia
Ending date: May 2009
Last updated: March 19, 2008