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.

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00461266

Enrollment

Registered

2007-04-17

Start date

2007-04-30

Completion date

2008-01-31

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Treatment Experienced

Brief summary

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.

Interventions

DRUGenfuvirtide [Fuzeon]

90mg sc bid

DRUGAntiretroviral therapy

As prescribed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Mean change in CD4 cell count from baseline	Week 24

Secondary

Measure	Time frame
Change in HIV RNA from baseline	Week 24
Change in HIV RNA and CD4 cell count	Weeks 24-48
Correlation between CD4 count and HIV RNA; OIs; QoL; ADEs; SAEs.	Throughout study

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026