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.

Condition(s) targeted: HIV Infections

Intervention: enfuvirtide [Fuzeon] (Drug); Antiretroviral therapy (Drug)

Phase: Phase 4

Status: Terminated

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-naïve 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

Secondary outcome:

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Carlton, Australia

Darlinghurst, Australia

Melbourne, Australia

Miami, Australia

Perth, Australia

South Yarra, Australia

Sydney, Australia

Ending date: May 2009
Last updated: March 19, 2008