INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure.

A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00615134

Enrollment

Registered

2008-02-14

Start date

2008-01-31

Completion date

2011-06-30

Last updated

2015-01-27

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 efficacy and safety of a new regimen of Fuzeon \+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s. c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is \<100 individuals.

Interventions

DRUGenfuvirtide [Fuzeon]

90mg sc bid

DRUGOptimized background ARV 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; * HIV-1 infection, with virologic failure; * on same stable HAART for \>4 weeks, with viral load \>1000 RNA copies/mL; * Fuzeon-naive.

Exclusion criteria

* coinfection with HIV-2; * active opportunistic infection in 4 weeks prior to screening; * cirrhosis or severe liver failure; * severe renal disease.

Design outcomes

Primary

Measure	Time frame
Percentage of patients with plasma viral load <50 copies/mL	Week 24

Secondary

Measure	Time frame
CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions.	Throughout study

Countries

France

Outcome results

None listed

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