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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.

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

enfuvirtide [Fuzeon]

Optimized background ARV therapy

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with plasma viral load <50 copies/mL

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00615134

First Posted

January 30, 2008

Last Updated

January 19, 2015

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00615134

Brief Title

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.

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

treatment experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

enfuvirtide [Fuzeon]

Intervention Description

90mg sc bid

Intervention Type

Drug

Intervention Name(s)

Optimized background ARV therapy

Intervention Description

As prescribed

Primary Outcome Measure Information:

Title

Percentage of patients with plasma viral load <50 copies/mL

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

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

Time Frame

Throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Aulnay Sous Bois

ZIP/Postal Code

93600

Country

France

City

Basse-terre

ZIP/Postal Code

97100

Country

France

City

Bordeaux

ZIP/Postal Code

33000

Country

France

City

Boulogne

ZIP/Postal Code

62321

Country

France

City

Caen

ZIP/Postal Code

14033

Country

France

City

Colmar

ZIP/Postal Code

68024

Country

France

City

Fort-de-france

ZIP/Postal Code

97261

Country

France

City

Garches

ZIP/Postal Code

92380

Country

France

City

La Roche Sur Yon

ZIP/Postal Code

85925

Country

France

City

Le Kremlin Bicêtre

ZIP/Postal Code

91275

Country

France

City

Levallois Perret

ZIP/Postal Code

92309

Country

France

City

Lyon

ZIP/Postal Code

69317

Country

France

City

Marseille

ZIP/Postal Code

13006

Country

France

City

Nantes

ZIP/Postal Code

44035

Country

France

City

Nice

ZIP/Postal Code

06202

Country

France

City

Nimes

ZIP/Postal Code

30029

Country

France

City

Paris

ZIP/Postal Code

75010

Country

France

City

Paris

ZIP/Postal Code

75571

Country

France

City

Paris

ZIP/Postal Code

75651

Country

France

City

Paris

ZIP/Postal Code

75674

Country

France

City

Paris

ZIP/Postal Code

75970

Country

France

City

Pessac

ZIP/Postal Code

33600

Country

France

City

Pointe À Pitre

ZIP/Postal Code

97159

Country

France

City

Poitiers

ZIP/Postal Code

86021

Country

France

City

Pontoise

ZIP/Postal Code

95303

Country

France

City

Rouen

ZIP/Postal Code

73031

Country

France

City

Saint Pierre

ZIP/Postal Code

97448

Country

France

City

Saint-denis

ZIP/Postal Code

97400

Country

France

City

Toulouse

ZIP/Postal Code

31052

Country

France

City

Tourcoing

ZIP/Postal Code

59208

Country

France

12. IPD Sharing Statement

Learn more about this trial

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.

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