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.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00615134
First received: January 30, 2008
Last updated: October 14, 2011
Last verified: October 2011
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Purpose
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 receive 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 Fuzeon, in the case of new virological failure. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: enfuvirtide [Fuzeon] Drug: Optimized background ARV therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Enfuvirtide
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Percentage of patients with plasma viral load <50 copies/mL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | January 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: enfuvirtide [Fuzeon]
90mg sc bid
Drug: Optimized background ARV therapy
As prescribed
|
| Active Comparator: 2 |
Drug: Optimized background ARV therapy
As prescribed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615134
Locations
| France | |
| Aulnay Sous Bois, France, 93600 | |
| Basse-terre, France, 97100 | |
| Bordeaux, France, 33000 | |
| Boulogne, France, 62321 | |
| Caen, France, 14033 | |
| Colmar, France, 68024 | |
| Fort-de-france, France, 97261 | |
| Garches, France, 92380 | |
| La Roche Sur Yon, France, 85925 | |
| Le Kremlin Bicêtre, France, 91275 | |
| Levallois Perret, France, 92309 | |
| Lyon, France, 69317 | |
| Marseille, France, 13006 | |
| Nantes, France, 44093 | |
| Nice, France, 06202 | |
| Nimes, France, 30029 | |
| Paris, France, 75970 | |
| Paris, France, 75674 | |
| Paris, France, 75475 | |
| Paris, France, 75571 | |
| Paris, France, 75651 | |
| Pessac, France, 33600 | |
| Pointe À Pitre, France, 97159 | |
| Poitiers, France, 86021 | |
| Pontoise, France, 95300 | |
| Rouen, France, 73031 | |
| Saint Pierre, France, 97448 | |
| Saint-denis, France, 97400 | |
| Toulouse, France, 31052 | |
| Tourcoing, France, 59208 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00615134 History of Changes |
| Other Study ID Numbers: | ML21287 |
| Study First Received: | January 30, 2008 |
| Last Updated: | October 14, 2011 |
| Health Authority: | France:Agence francaise de securite sanitaire des produits de sante (AFSSAPS) |
Keywords provided by Hoffmann-La Roche:
|
treatment experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Enfuvirtide HIV Fusion Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013