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.

Hoffmann-La Roche

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

HIV Infections

Interventions

enfuvirtide [Fuzeon]DRUG

90mg sc bid

Antiretroviral therapyDRUG

As prescribed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Carlton, Australia

Unnamed facility

Darlinghurst, Australia

Unnamed facility

Melbourne, Australia

Unnamed facility

Miami, Australia

Unnamed facility

Outcomes

Primary Outcomes

Mean change in CD4 cell count from baseline

Time frame: Week 24

Secondary Outcomes

Change in HIV RNA from baseline

Time frame: Week 24

Change in HIV RNA and CD4 cell count

Time frame: Weeks 24-48

Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.

Time frame: Throughout study

Data from ClinicalTrials.gov

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